[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatic-impairment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatic-impairment":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,43,67,90,111,130,150,175,196,217,242,264,287,307,331,358,382,410,431,450],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100644851","phase-1-a-study-to-learn-how-the-study-medicine-called-atirmociclib-is-handled-by-the-body-in-people-with-normal-liver-function-and-different-levels-of-liver-disease-100644851",false,"NCT07677358","A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease","A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF ATIRMOCICLIB IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION","Inclusion criteria including but not limited to:\n\n* BMI of 17.5-40 kg\u002Fm2; and a total body weight \\>50 kg (110 lb).\n* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n* Capable of giving signed informed consent.\n\nNormal hepatic function group only:\n\n\\- Overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and standard 12-lead ECGs.\n\nHepatic impairment groups only:\n\n\\- Stable hepatic impairment meeting the criteria for Child-Pugh Class A, B, or C . Stable hepatic impairment is defined as no clinically significant change in disease status within the last 28 days prior to the screening visit, as documented by the participant's recent medical history.\n\nExclusion criteria including but not limited to:\n\n* Any condition or history of surgery possibly affecting drug absorption.\n* Use of prohibited prior or concomitant medications.\n\nNormal hepatic function group only:\n\n\\- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n\nHepatic impairment groups only:\n\n\\- A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI.",true,"ALL","18 Years",{"count":20,"type":21},28,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health.\n\nThe study is seeking participants who are:\n\n* Aged 18 years or older\n* Have a BMI of 17.5 to 40 kg\u002Fm2, and body weight more than 50 kg.\n* Have normal liver function or have stable mild, moderate, or severe liver disease\n\nParticipants will receive study medicine by mouth. Blood samples will be collected to see how much of the medicine is in the body over time. This will help understand whether liver disease changes how the medicine is handled.\n\nParticipants will be in the study for about 9 weeks. Those with normal liver function will stay in the clinic for about 7 days. People with liver disease will stay for about 9 days. After leaving the clinic, people may be contacted for follow-up. This may be done by phone or through a clinic visit.",[27,28,29],"Hepatic Impairment","Healthy, Hepatic Insufficiency","Healthy Adults","NOT_YET_RECRUITING","2026-06-24",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":21},"2026-07-09",{"date":38,"type":21},"2027-09-10",{"name":40,"class":41},"Pfizer","INDUSTRY",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":42},"100592734","phase-1-effect-of-hepatic-impairment-on-the-pharmacokinetics-of-mirdametinib-100592734","NCT06997276","Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib","A Phase 1 Open-Label Study to Assess the Pharmacokinetics of Mirdametinib and Its Metabolite PD-0315209 in Participants With Impaired Hepatic Function and Participants With Normal Hepatic Function","Inclusion Criteria (All Participants):\n\n* Participant understands the study procedures, is willing to comply with all study requirements and restrictions and agrees to participate in the study by providing written informed consent, prior to any study-related procedures being performed.\n* Participant is between 18 and 80 years of age (inclusive) at the time of informed consent.\n* Participant has a body mass index (BMI) ≥18 kg\u002Fm2 and ≤32 kg\u002Fm2 (inclusive) at Screening and Day -1 and a total body weight \\>50 kg.\n* Male participants that agree to the following during the treatment periods and for at least 90 days after the last dose of study treatment:\n\n  1. Refrain from donating or preserving sperm; PLUS either\n  2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR\n  3. Must agree to use a male condom when having sexual intercourse with women of childbearing potential (WOCBP). An additional form of contraception as described in Appendix 4 of the protocol should also be used by the female partner if she is of childbearing potential. Refer to Appendix 4 of the protocol for definition of WOCBP.\n* Female participants that are not pregnant or breastfeeding, and for whom one of the following conditions applies:\n\n  1. Refrain from donating or preserving eggs for at least 90 days after the last dose of study treatment PLUS either\n  2. Is a woman of non-childbearing potential, as defined in Appendix 4 OR\n  3. Is a WOCBP and agrees to use an acceptable contraceptive method as described in Appendix 4 from the time of informed consent and for at least 90 days after the last dose of study treatment; AND\n  4. WOCBP and post-menopausal women must have a negative serum pregnancy test at Screening and on CRU admission on Day -1 unless confirmed as surgically sterile.\n* Participant has sufficiently good venous access in at least one arm to confidently enable serial blood sampling.\n\nInclusion Criteria (Participants with Hepatic Impairment):\n\n* Participant has chronic (\\>180 days), stable hepatic insufficiency, with no acute episodes of illness or liver injury within 28 days prior to Screening due to deterioration in hepatic function and must remain stable through the Screening Period.\n* Concomitant medications for the management of an individual participant's medical history should be stable for at least 28 days prior to dose of study treatment. On a case-by-case basis, with approval from the Sponsor, participants receiving fluctuating concomitant medications and treatment may be considered if the underlying disease is under control and is not contraindicated by stated medication exclusions.\n* Aside from hepatic impairment, the participant must, in the opinion of the Investigator, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and screening laboratory evaluations.\n* Participant has normal or mildly impaired renal function as evidenced by estimated glomerular filtration rate (eGFR) determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula (i.e., ≥ 60 mL\u002Fmin\u002F1.73 m2) or local standard.\n* Participant is willing and able to abstain from alcohol throughout the duration of the study (from Screening to FU phone call) and has a negative breath alcohol test at Screening and CRU admission (Day -1).\n* Participant may be enrolled if the criteria for moderate hepatic impairment based on Child-Pugh Classification Class B (Cohort 1) or severe hepatic impairment based on Child-Pugh Classification C (Cohort 3) is satisfied within 28 days prior to Day 1 and still at CRU admission (Day -1).\n\nInclusion Criteria (Healthy Control Participants):\n\n* Participant is considered to be medically healthy, as determined by a responsible and experienced Investigator, based on a clinical evaluation (including medical history, physical examination, clinical laboratory tests, vital sign measurements, and a 12-lead ECG performed as directed in the SoA (Section 1.3), and the results of clinical chemistry, hematology, and urinalysis carried out at Screening and Day -1.\n* Participant is considered to be without hepatic disease and has normal hepatic function at screening and check-in (serum bilirubin, serum albumin, and international normalized ratio \\[INR\\]). Participants may be included if the alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] levels are below or within reference ranges. Participants will not be included if the ALT, AST, total serum bilirubin, and INR are outside the upper limit of normal per the local labs. In addition, participants will not be included if the serum albumin is below the lower limit of normal per the local labs.\n* If these tests are out of range, one laboratory repeat will be allowed at screening and upon check-in on Day -1.\n* Participant's age at Screening must be within 10 years of the Day -1 age for the intended paired participant.\n* Participant's BMI at Screening must be within 20% of the Day -1 BMI for the intended paired participant.\n* Participant has normal renal function as evidenced by eGFR as calculated by the CKD-EPI creatinine formula (i.e., ≥ 60 mL\u002Fmin\u002F1.73 m2) or local standard.\n\nExclusion Criteria (All Participants):\n\n* Participant is deemed unsuitable for this study in the opinion of the Investigator for any additional reason, condition, or prior therapy.\n* Participant has clinically significant infections (e.g., coronavirus disease 2019 \\[COVID-19\\] or influenza) within 90 days prior to Day 1, as judged by the Investigator, or evidence of any infection with the past 14 days prior to Day 1.\n\nChronic infection with Hepatitis B or C (\\>180 days) may be eligible as judged by the Investigator in consultation with the Sponsor's medical monitor. If a participant tests positive for HIV at Screening, they are not eligible for participation in the study.\n\n* Participant has a history of stomach or gastrointestinal (GI) surgery or resection that would potentially alter absorption, metabolism, and\u002For excretion of PO administered drugs (exceptions include participants who underwent appendectomy, cholecystectomy, or any type of hernia repair).\n* Participant has a history of pre-existing condition (apart from hepatic impairment) interfering with normal GI anatomy or motility and potentially alter the absorption, metabolism, and\u002For excretion of orally administered drugs.\n* Participants with a history of inflammatory bowel disease, peptic ulceration, or pancreatitis within the 180 days prior to Day 1.\n* Participant has a history of cancer, except if judged to be in full remission for at least 5 years at the time of informed consent (except basal cell skin cancer, resected prostate cancer with an undetectable PSA, or squamous cell skin cancer with history of curative treatment and no recurrence for at least 3 years prior to Screening), as judged by the Investigator.\n* Participant has an acute illness with symptom or treatment that has started or persisted within 14 days prior to study treatment administration unless mild in severity and enrollment is approved by both Investigator and Sponsor's medical monitor.\n* Participant has a history of postural hypotension, unexplained syncope, or a Day -1 blood pressure (BP) that is less than 90 mmHg systolic or 40 mmHg diastolic.\n* Participant has intraocular pressure (IOP) \\>21 mmHg or any evidence of glaucoma or retinal vein occlusion at Screening or Day -1.\n* Participant has a known hypersensitivity or intolerance to any of the study treatments, or excipients thereof, or a history of drug or other allergy that, in the opinion of the Investigator or Sponsor medical monitor, contraindicates their participation.\n* Participant has received any P-glycoprotein or breast cancer resistance protein inhibitors within 14 days or 5 half-lives (whichever is longer) prior to Day 1. See Appendix 5 for examples of these agents.\n* Participant has a history of excessive intake of alcohol, defined as an average daily intake of greater than 3 units, or an average weekly intake of greater than 14 units (one unit is equivalent to one can or bottle (250 mL) of beer, or one measure (35 mL) of spirits, or one glass (100 mL) of wine) in the last 6 months prior to Screening.\n* Participant has consumed food containing poppy seeds within 72 hours of Screening and Day -1 as outlined in Section 5.3.1.\n* Participant has donated blood or had a loss of more than 450 mL of blood within 60 days or donation of plasma within 7 days prior to Screening.\n* Participant has received blood products within the 60 days prior to Screening.\n* Participant is unwilling to avoid strenuous or unaccustomed activity, sunbathing, or contact sports within 96 hours prior to admission to the CRU and until discharge from the CRU.\n* Participant has abnormal QT interval corrected by Fridericia's formula (QTcF), defined as \\>450 msec (single ECG) at Screening and Day -1.\n* If the ECG shows an abnormal QTcF, repeat the ECG after 30 minutes to determine whether the finding is confirmed.\n\nExclusion Criteria (Participants with Hepatic Impairment):\n\n* Participant has a history of Gilbert's syndrome, history of biliary sepsis within the past 2years, or a portosystemic shunt.\n* Participant has hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as less than 1 year).\n* Participant has previously received a transplanted kidney, liver, or heart.\n* Participant has history of GI hemorrhage due to esophageal varices or peptic ulcers less than 28 days prior to Screening.\n* Participant has acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and\u002For laboratory signs of hepatic impairment in the judgment of either the Investigator or the Sponsor's medical monitor.\n* NOTE: Participants with previously treated Hepatitis B, who have had a non-detectable viral load for at least 6 months prior to Day 1, and are considered clinically stable by the Investigator, may be considered for study participation. If the participant is Hepatitis C reactive, they may be allowed in the study if the viral load is non-detectable per Hepatitis C RNA testing.\n* Participant has heart rate (HR) that is \\\u003C50 bpm or \\>100 bpm after resting in a supine position for 5 minutes at Screening and Day -1.\n* Participant has history of right heart failure or uncontrolled ascites.\n* Participant has persistent severe or uncontrolled hypertension, i.e., supine BP\n\n  * 150 mmHg (systolic) or ≥100 mmHg (diastolic), following at least 5 minutes of supine rest. If repeated measures are needed for confirmation, two additional measurements should be taken and the average of three measurements should be used to determine eligibility.\n\nExclusion Criteria (Healthy Control Participants):\n\n* Participant has evidence of a clinically significant deviation from normal in the physical examination, vital signs, ECG readings, or clinical laboratory determinations at Screening and Day -1.\n* Participant has evidence of clinically significant hepatic illness or abnormalities.","80 Years",{"count":52,"type":21},32,[24],"The purposes of this study are to determine:\n\n* The pharmacokinetics (the amount of study drug in your blood and how long it takes the body to get rid of it) of the study drug and its metabolites (substances produced as the body breaks down the study drug) in participants with moderate or severe liver function impairment compared to participants with normal liver function (also known as a healthy volunteer). Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug.\n* How well the study drug is tolerated and any side effects that may occur in participants with moderate or severe liver function impairment compared to participants with normal liver function.\n\nThis study is for research purposes only and is not intended to treat any medical condition.",[56,27],"Healthy","RECRUITING","2026-06-17",{"date":60,"type":34},"2026-06-22",{"date":62,"type":34},"2025-05-07",{"date":64,"type":21},"2026-09-30",{"name":66,"class":41},"SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":42},"100612073","phase-1-a-study-to-assess-the-drug-levels-and-safety-of-bms-986435-in-participants-with-normal-hepatic-function-and-participants-with-different-degrees-of-hepatic-impairment-100612073","NCT07248839","A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic Impairment","A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Mild and Moderate Hepatic Impairment","Inclusion Criteria:\n\n* Participant must have documented LVEF ≥ 60% (2D biplane Simpson's Method) and absence of cardiac abnormality.\n* Participant must have body weight of \\> 50 kg and BMI of 18.0 kg\u002Fm2 through 40 kg\u002Fm2, inclusive, at screening.\n* Participants must have adequate renal function at screening as evidenced by an eGFR \\> 60 mL\u002Fmin\u002F1.73 m2 for participants calculated with the CKD-EPI Creatinine Equation (2021).\n\nExclusion Criteria:\n\n* Participants must not have history of or current uncontrolled or unstable clinically significant disorder, condition, or disease that, in the opinion of the investigator and CRO MM, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.\n* Participants must not have head injury in the last 2 years, intracranial tumor, or aneurysm.\n* Participants must not have history of malignancy of any type, except in situ cervical cancer \\>5 years prior to the screening visit or surgically excised non-melanomatous skin cancer \\>2 years prior to the screening visit.\n* Participants must not have History of heart disease (including coronary artery disease, heart failure\u002FLV systolic dysfunction, cardiomyopathy, or clinically significant structural disease).\n* Other protocol defined inclusion\u002Fexclusion criteria applies.","75 Years",{"count":76,"type":21},24,[24],"The purpose of this study is to determine the pharmacokinetic and safety of BMS-986435 in participants with normal hepatic function and participants with different degrees of hepatic impairment",[80,27],"Healthy Volunteers","2026-06-10",{"date":83,"type":34},"2026-06-12",{"date":85,"type":34},"2025-12-15",{"date":87,"type":21},"2026-08-05",{"name":89,"class":41},"Bristol-Myers Squibb",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100643595","phase-1-a-study-to-evaluate-the-pharmacokinetics-pk-and-safety-of-a-single-dose-of-treprostinil-palmitil-inhalation-powder-tpip-in-participants-with-normal-hepatic-function-and-participants-with-hepatic-impairment-100643595","NCT07643155","A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment","An Open-label, Phase 1 Trial to Evaluate the Pharmacokinetics and Safety of a Single Dose of 80 μg Treprostinil Palmitil Inhalation Powder in Participants With Normal Hepatic Function and Participants With Hepatic Impairment","Inclusion Criteria:\n\n* Body mass index between 18.0 and 40.0 kilograms per square meter (kg\u002Fm\\^2), inclusive.\n\nInclusion Criteria for Participants with Normal Hepatic Function\n\n* In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements, and clinical laboratory assessments (congenital nonhemolytic hyperbilirubinemia \\[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\\] is not acceptable) at screening and check-in, as assessed by the investigator (or designee).\n\nInclusion Criteria for Participants With Hepatic Impairment:\n\n* Diagnosis of chronic (\\>6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history.\n* Participants with type 2 diabetes mellitus may be included, if they have:\n\n  * glycosylated hemoglobin A1C ≤8.5% at screening\n  * fasting blood glucose ≤240 milligrams per deciliter (mg\u002FdL), while participant is using their normal diabetes medication, at screening and check-in.\n\nExclusion Criteria:\n\n* History of stomach or intestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair are allowed).\n* Use or intend to use any moderate or strong inducers or inhibitors of CYP2C8 or CYP2C9 within 30 days prior to dosing.\n* Participation in a clinical trial involving administration of an investigational medicinal product (IMP) (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer.\n\nExclusion Criteria for Participants with Normal Hepatic Function\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).\n* Positive hepatitis panel and\u002For positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.\n* Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in. Results that are compatible with marijuana use are not exclusionary.\n\nExclusion Criteria for Participants With Hepatic Impairment:\n\n* Current organ transplant or waiting for organ transplant scheduled to occur during the trial.\n* Hospitalization for hepatic encephalopathy within 3 months prior to dosing.\n* Encephalopathy ≥Grade 2.\n* History of drug\u002Fchemical abuse within 1 year prior to check-in. Marijuana use is not exclusionary.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","70 Years",{"count":99,"type":21},30,[24],"The primary purpose of the study is to determine the effect of mild, moderate, and severe hepatic impairment on the PK of total treprostinil palmitil (TP) and treprostinil (TRE) following a single dose of 80 micrograms (μg) TPIP, when compared to normal hepatic function.",[27],"2026-06-08",{"date":105,"type":34},"2026-06-11",{"date":81,"type":21},{"date":108,"type":21},"2027-02-07",{"name":110,"class":41},"Insmed Incorporated",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":42},"100594738","phase-1-a-study-to-test-how-bi-1291583-is-taken-up-in-the-blood-of-people-with-and-without-liver-problems-100594738","NCT07023354","A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems","Open Label, Single Dose, Parallel-group Study to Evaluate the PK and the Safety and Tolerability of Single Oral Doses of BI 1291583 in Trial Participants With Mild, Moderate and Severe Hepatic Impairment as Compared to Matched, Hepatically Healthy Trial Participants.","Inclusion Criteria :\n\n1. Male or female trial participants aged ≥18 and ≤80 years at screening\n2. Body Mass Index (BMI) of 18.5 to 42 kg\u002Fm² (inclusive)\n3. Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Harmonized Guideline for Good Clinical Practice (GCP) and local legislation prior to admission to the trial\n4. Female trial participants who meet any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 5 months after trial dosing\n\n   * Use of combined (oestrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom\n   * Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom\n   * Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) plus use of condom\n   * Sexually abstinent\n   * A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant\n   * Surgically sterilised (including hysterectomy) plus use of condom\n   * Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle Stimulating Hormone (FSH) above 25 U\u002FL and oestradiol below 30 ng\u002FL is confirmatory)\n\nIn addition to the overall inclusion criteria given, trial participants with impaired hepatic function must fulfil the following criteria:\n\n1. Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points) or Child Pugh C (score 10-15 points)\n2. Absence of significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at both screening and admission to trial site, with the exception of findings that in the opinion of the investigator are consistent with the participant's hepatic impairment\n3. Medication and\u002For treatment regimens must have been stable (i. e., no dose adjustments) for at least 7 days or 5 half-lives (whichever is longer) prior to the planned randomisation and should be kept stable until study completion. Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investigator and the sponsor's medical monitor\n\nIn addition to the overall inclusion criteria given, trial participants with normal hepatic function must fulfill the following criteria:\n\n1\\. Individually matched to trial participation with hepatic impairment according to sex, age, smoking habit and weight\n\nExclusion Criteria:\n\nExclusion criteria applying to all trial participants:\n\n1. Any medical condition or finding in the medical examination that in the investigator's opinion assessed as clinically relevant, poses a safety risk for the trial participant or may interfere with the study objectives (except for conditions associated with hepatic impairment in trial participant with compromised hepatic function)\n2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (apart from values due to underlying disease)\n3. Severe gastrointestinal, renal (estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease Epidemiology (CKD-EPI) \\\u003C40 ml\u002Fmin\u002F1.73 m2 for the hepatic impaired trial participants and Estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease Epidemiology (CKD-EPI) \\\u003C60 ml\u002Fmin\u002F1.73 m2 for matched controls), respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the Investigator\n4. Alpha fetoprotein \\>50 ng\u002FmL (\\>50 µg\u002FL) at screening\n5. Surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except cholecystectomy, appendectomy or simple hernia repair)\n6. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders\n7. History of relevant orthostatic hypotension, fainting spells, or blackouts\n8. Relevant chronic or acute infections\n9. Further exclusion criteria apply",{"count":52,"type":21},[24],"This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 18.5 to 42 kg\u002Fm². People with or without liver problems can take part in the study. The purpose of this study is to find out how much of a medicine called BI 1291583 gets into the blood of people with and without liver problems. BI 1291583 is being developed to treat people with bronchiectasis, a chronic disease of the lungs. People living with this condition often also have liver problems. Therefore, it is important to find out whether liver problems influence the amount of BI 1291583 that gets into the blood.\n\nStudy participants receive a single dose of BI 1291583 as a tablet taken by mouth. Participants are divided into 4 groups based on how well their liver works: 1 group without liver problems, and 3 groups with mild, moderate, and severe liver problems. Each participant without liver problems is matched with participants from the other groups based on factors such as age, sex, smoking habits, and body weight to ensure accurate comparisons.\n\nParticipants are in the study for about 3 months. They stay for 3 days at the study site and also visit the study site up to 9 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The doctors regularly check participants' health and take note of any unwanted effects.",[56,27],{"date":123,"type":34},"2026-06-09",{"date":125,"type":34},"2025-07-17",{"date":127,"type":21},"2026-09-17",{"name":129,"class":41},"Boehringer Ingelheim",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100604022","phase-1-a-study-to-evaluate-the-effect-of-moderate-or-severe-hepatic-impairment-on-the-pharmacokinetics-pk-of-inavolisib-100604022","NCT07144111","A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib","A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib","Inclusion Criteria:\n\nAll participants:\n\n* Body Mass Index 18.0 to 40.0 kilogram per meter square (kg\u002Fm\\^2), inclusive, and body weight \\>=45 kg.\n* Negative hepatitis B surface antigen (HBsAg) test\n* Positive hepatitis B surface antibody (HBsAb) test or negative HBsAb\n* Negative HIV (Human Immunodeficiency Virus) test\n* Females will not be pregnant or breastfeeding and must be either postmenopausal or surgically sterile\n* Males will agree to use contraception and will refrain from sperm donation\n\nHealthy participants (Cohort 1):\n\n* Negative hepatitis C virus (HCV) antibody test or positive HCV antibody test followed by a negative HCV RNA test\n* Normal hepatic function and no history of clinically significant hepatic dysfunction\n\nParticipants with Hepatic Impairment (Cohorts 2 and 3):\n\n* Considered to have moderate (Child-Pugh score of 7 to 9) or severe (Child-Pugh score of 10 to 15) hepatic impairment\n* Chronic, stable hepatic insufficiency with features of cirrhosis\n* Negative hepatitis C viral load\n\nExclusion Criteria:\n\nAll participants:\n\n* History of Type 1 diabetes or Type 2 Diabetes that is insulin-dependent or requires ongoing systemic treatment with two or more agents\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder\n* Significant illness, surgery, or hospitalization within 2 weeks prior to dosing.\n* History of gastro-intestinal surgery\n* Malabsorption syndrome or any other condition that would interfere with enteral absorption.\n* History of active or latent Mycobacterium tuberculosis (TB), regardless of treatment history, or positive QuantiFERON® TB Gold test\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance\n* Use of drugs of abuse (including opioids)\n\nHealthy participants (Cohort 1):\n\n\\- History of alcoholism or drug addiction\n\nParticipants with Hepatic Impairment (Cohorts 2 and 3):\n\n* Hepatic impairment due to hepatocellular carcinoma or bile duct cancer\n* Surgical or artificial portosystemic shunt (e.g., transjugular intrahepatic portosystemic shunt)\n* Evidence of hepatorenal syndrome\n* Ascites requiring paracentesis\n* Any evidence of progressive liver disease in the last 1 month\n* Receipt of a liver transplant\n* Hepatic encephalopathy Grade 2 or above",{"count":52,"type":21},[24],"This open-label study will evaluate the effect on the pharmacokinetics (PK), safety, and tolerability of a single oral dose of inavolisib in participants with moderate or severe hepatic impairment compared with demographically matched healthy participants with normal hepatic function.",[27],"2026-06-04",{"date":103,"type":34},{"date":144,"type":34},"2025-08-21",{"date":146,"type":21},"2026-09-06",{"name":148,"class":41},"Genentech, Inc.",4,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":149},"100634982","phase-1-a-phase-i-study-to-investigate-the-effect-of-hepatic-impairment-of-azd9550-and-azd6234-100634982","NCT07546760","A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234","A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD9550 and AZD6234","Inclusion Criteria\n\n1. Age 18-85 years at consent.\n2. Groups:\n\n   * Healthy controls: Medically healthy; no clinically significant findings in history, exam, labs, vitals, or 12 lead ECG (per investigator).\n   * Hepatic impairment: Chronic (≥6 months), stable; documented Child Pugh B (Group 2) or C (Group 1).\n3. Stable concomitant regimen ≥2 weeks before screening (Groups 1-2).\n4. T2DM allowed if HbA1c \\\u003C10% and no severe hypo\u002Fhyperglycaemia or hospitalisation within 6 months.\n5. Body weight ≥50 kg; BMI 18-42 kg\u002Fm².\n6. Sex assigned at birth (male\u002Ffemale); contraception per local regulations. Females of child bearing potential: negative pregnancy tests and condoms plus one highly effective method through 54 days post last dose. Males: condom use; no sperm donation through 54 days post last dose.\n7. Written informed consent; separate consent for optional genomics.\n\nExclusion Criteria\n\nHealthy controls only:\n\n1. Any clinically significant disease; Diabetes;\n2. lab values i) ALT\u002FAST\u002FALP \\>1.5×ULN; ii) WBC\u002Fplatelets \\\u003CLLN; iii) haemoglobin \\\u003C11.0 g\u002FdL (female) or \\\u003C12.0 g\u002FdL (male); aPTT or PT\u002FINR \\>1.2×ULN; iv) total bilirubin \\>1.5×ULN (or Gilbert's);\n3. abnormal resting vital signs i) SBP \\>150 or \\\u003C90 mmHg, ii) DBP \\>95 or \\\u003C50 mmHg, iii) pulse ≥100 or ≤45 bpm;\n4. QTcF \\>450 ms or clinically significant ECG abnormalities;\n5. severe allergy\u002Fhypersensitivity;\n6. major surgery within 30 days;\n7. pancreatitis or pancreatic enzymes \\>2×ULN;\n8. triglycerides \\>500 mg\u002FdL (5.6 mmol\u002FL);\n9. calcitonin \\>50 ng\u002FL (50 pg\u002FmL);\n10. severe vitamin D deficiency (\\\u003C12 ng\u002FmL, 30 nmol\u002FL);\n11. low corrected or ionised calcium;\n12. HIV positive; HBV surface\u002Fcore Ab or HCV Ab positive; drug\u002Falcohol abuse within 1 year.\n\n    Hepatically impaired only:\n13. Unstable medical\u002Fpsychological conditions or uncontrolled systemic disease;\n14. eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m² (CKD EPI 2021);\n15. Abnormal resting vital signs i) SBP \\>160 or \\\u003C100 mmHg, ii) DBP \\>110 or \\\u003C65 mmHg, iii) pulse ≥100 or ≤50 bpm;\n16. platelets \\\u003C35×10⁹\u002FL; neutrophils \\\u003C1.2×10⁹\u002FL; haemoglobin \\\u003C85 g\u002FL; HbA1c ≥10%;\n17. oesophageal banding within 3 months or GI bleeding within 6 months;\n18. ascites requiring paracentesis and albumin ≤4 week intervals; paracentesis within 30 days;\n19. fluctuating\u002Fworsening hepatic function during screening; hepatocellular carcinoma;\n20. acute liver disease due to infection\u002Fdrug; hepatic impairment due to non liver disease;\n21. biliary obstruction or non parenchymal causes; hepatic encephalopathy Grade ≥2;\n22. functioning organ transplant or anticipated within 2 months; prior porto systemic shunt\u002FTIPS;\n23. QTcF \\>480 ms or clinically significant ECG abnormalities;\n24. pancreatitis or pancreatic enzymes \\>2×ULN;\n25. triglycerides \\>500 mg\u002FdL (5.6 mmol\u002FL); calcitonin \\>50 ng\u002FL (50 pg\u002FmL); severe vitamin D deficiency (\\\u003C12 ng\u002FmL, 30 nmol\u002FL); ionised calcium \\\u003CLLN;\n26. neoplastic disease within 10 years (except adequately treated BCC\u002FSCC or in situ cervical); MEN2 or medullary thyroid carcinoma (personal or first degree relative); significant gastric emptying abnormality;\n27. HIV positive; HBV surface\u002Fcore Ab or HCV Ab positive (may be included if HBV DNA or HCV RNA negative on follow up); drug\u002Falcohol abuse within 1 year.\n28. Exposure to a new chemical entity within 30 days or 5 half lives (whichever longer) before intervention; prior exposure to AZD9550 or AZD6234;\n\n    Prior\u002Fconcomitant therapy:\n\n    Healthy controls:\n29. use of prescription\u002Fnon prescription\u002Fsupplements within 7 days (or 14 days for enzyme inducers) or 5 half lives before intervention unless judged non interfering; current oral contraceptives or oestrogen HRT.\n\n    Hepatically impaired:\n30. prohibited-weight loss medicines (including GLP 1), agents causing significant weight gain (e.g., systemic glucocorticoids, antipsychotics), GLP 1 RAs for diabetes, QT prolonging\u002Fprokinetic agents, oral contraceptives for contraception; restricted-short systemic glucocorticoids (≤7 days), 5HT 3 antiemetics at lowest effective dose, combined oral contraceptives for non contraceptive indications. If diabetes develops and requires insulin\u002FSU\u002FGLP 1 RA, discontinue from study.\n\n    Other:\n31. prior enrolment in this study (screened without dosing permitted). Positive drugs of abuse and\u002For alcohol screen (except prescribed meds in hepatic impairment); recent blood products\u002Fdonation per protocol thresholds; employees or close relatives; vulnerable populations; unlikely to comply (investigator judgement).","85 Years",{"count":20,"type":21},[24],"The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with normal hepatic function.",[27],[163,164,165],"Moderate","Severe","Matched Healthy Controls","2026-06-02",{"date":168,"type":34},"2026-06-03",{"date":170,"type":34},"2026-03-20",{"date":172,"type":21},"2027-02-04",{"name":174,"class":41},"AstraZeneca",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":42},"100613646","phase-1-a-study-to-learn-how-the-body-processes-the-study-medicine-pf-07328948-in-people-with-and-without-reduced-liver-function-100613646","NCT07269301","A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function","A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF PF-07328948 IN ADULTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIRMENT","Inclusion Criteria:\n\n* Male or female of nonchildbearing potential, between the ages of 18 (inclusive) and 75 years, at the screening visit.\n* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n* BMI of 17.5 to 40.0 kg\u002Fm2 (inclusive), and a total body weight ≥45 kg (99 lb).\n* Group 4 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.\n* Group 4 only: no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests.\n* Groups 1, 2 \\& 3 only: stable hepatic impairment that meets criteria for Class A, B, or C of the Child-Pugh classification with no clinically significant change in disease status within 28 days before screening.\n* Groups 1, 2 \\& 3 only: stable concomitant medications for the management of individual participant's medical history.\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption\n* At screening, a positive result for HIV antibodies.\n* Evidence of a prothrombotic state, including history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis, or known genetic predisposition.\n* Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n* Use of specific prohibited prior\u002Fconcomitant therapies\n* Use of an investigational product within 30 days or 5 half-lives (whichever longer).\n* eGFR\\\u003C60 mL\u002Fmin\u002F1.73m2 at screening.\n* A positive urine drug test at screening or admission to study clinic.\n* At screening or admission to study clinic, a positive breath alcohol test.\n* History of alcohol abuse or binge drinking and\u002For any other illicit drug use or dependence within 6 months of screening.\n* Group 4 only: evidence of chronic liver disease including history of hepatitis, hepatitis B, or hepatitis C.\n* Group 4 only: screening ECG demonstrating QTcF interval \\>450 ms or a QRS interval \\>120 ms.\n* Group 4 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg\n* Group 1, 2 \\& 3 only: Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as \\\u003C1 year in Groups 2 \\& 3 and \\\u003C6 months for Group 1 only).\n* Group 1, 2 \\& 3 only: a diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical exam, liver biopsy, hepatic ultrasound, CT scan, or MRI.\n* Group 1, 2 \\& 3 only: history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening.\n* Group 1, 2 \\& 3 only: signs of clinically active Grade 3 or 4 hepatic encephalopathy\n* Groups 1, 2 \\& 3 only: severe ascites and\u002For pleural effusion, except for those categorized in Group 4 who may be enrolled provided participant is medically stable, per the study doctor's judgment.\n* Groups 1, 2 \\& 3 only: previously received a kidney, liver, or heart transplant.\n* Groups 1, 2, \\& 3 only: screening ECG demonstrating a QTcF interval \\>470 ms or a QRS interval \\>120 ms.\n* Groups 1, 2 \\& 3 only: persistent severe, uncontrolled hypertension at screening, admission to study clinic, or pre-dose on Day 1.\n* Groups 1, 2 \\& 3 only: ALT or AST \\>5x upper limit of normal on clinical laboratory tests at screening.","74 Years",{"count":184,"type":21},26,[24],"The purpose of this study is to understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people.\n\nStudy is seeking participants who:\n\n* Are between 18 and 75 years of age.\n* Have a BMI (body mass index) of 17.5 to 40 kg\u002Fm2, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds.\n\nParticipants will take the study medicine as a tablet once at the study clinic and then will stay onsite for about 6 days.\n\nDuring this time, the study team will check for the participant's treatment experience and take some blood samples to test the level of PF-07328948. This will help understand if certain level of decreased liver function could affect the study medicine being processed in the body.",[27,56],"2026-05-22",{"date":190,"type":34},"2026-05-26",{"date":192,"type":34},"2025-12-22",{"date":194,"type":21},"2027-02-23",{"name":40,"class":41},{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},"100630317","phase-1-a-study-to-test-how-bi-3000202-is-taken-up-in-the-blood-of-people-with-and-without-liver-problems-100630317","NCT07486102","A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems","A Phase I, Open-label, Single-dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of BI 3000202 in Adults","Inclusion Criteria :\n\n* Adult participants ≥18 years and ≤80 years of age at Visit 1.\n* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to participation in the trial.\n* Male and female participants. Women of childbearing potential must be willing and able to use a highly effective method of contraception per ICH M3 (R2) that results in a low failure rate (i.e. \\\u003C1% per year when used consistently and correctly) for the duration of the trial until at least 14 days after drug administration. Throughout the trial and for a period of at least 14 days after investigational medicinal product (IMP) administration, male participants with sexual partners who are women of child-bearing potential must use condoms or practice complete abstinence.\n* Body mass index (BMI) of 18.5-42.0 kg\u002Fm² (inclusive) at Visit 1.\n\nInclusion criteria Cohort 4 (participants with normal hepatic function)\n\n\\- Clinically healthy based on medical history, physical examination, vital signs, Electrocardiogram (ECG), and laboratory tests at Visit 1.\n\nInclusion criteria Cohorts 1, 2 and 3 (participants with hepatic impairment)\n\n* Hepatic impairment that meets the criteria for Child-Pugh classes A (Cohort 1), B (Cohort 2), or C (Cohort 3).\n* Hepatic decompensation therapies (e.g., diuretics for ascites, lactulose for hepatic encephalopathy, nonselective betablockers for portal hypertension) need to comply with following requirements:\n\n  * No new initiation or permanent discontinuation is permitted within 3 months prior to Visit 1.\n  * Major dose modifications (\\>50% change from baseline) within 4 weeks prior to Visit 1 are exclusionary.\n  * Minor titrations consistent with standard clinical management are permitted, provided the investigator confirms that the patient's underlying condition is clinically controlled. Cases involving fluctuating hepatic directed regimens may be included only if both the investigator and the sponsor agree that the patient's clinical condition is controlled and suitable for trial participation.\n\nExclusion Criteria :\n\n* Participation in another clinical trial within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior Visit 2.\n* Known hypersensitivity to BI 3000202 or any of its excipients.\n* Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1 (except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix (treated \\>3 years); patients with a remote history of malignancy (≥5 years prior) may be considered and must be discussed with sponsor on a case-by-case basis.\n* Have received stem cell transplantation.\n* Have received live or attenuated vaccination within 8 weeks prior to Visit 2.\n* Have received Bacillus Calmette-Guérin (BCG) vaccines ≤1 year prior to Visit 2.\n* Presence of relevant chronic or acute infections, including active systemic infection requiring antibiotics within 6 weeks prior to Visit 2.\n* Active or latent tuberculosis (TB).\n\n  * Participants with active TB will always be excluded.\n  * Participants with latent TB will be excluded if tested positive for Interferon-gamma release assay (IGRA) (QuantiFERON®-TB Gold Plus or T-SPOT®.TB) at Visit 1, not having completed appropriate treatment per local practice\u002Fguidelines for TB within the past 3 years and at least 1 month before Visit 2.\n  * Participants with indeterminate QuantiFERON®-TB Gold Plus or borderline or invalid T-SPOT®. TB may be retested with IGRA (once) and will be excluded if retesting is inconclusive or positive.\n  * Under exceptional circumstances and only after discussion with the sponsor, purified protein derivative (PPD) skin test can be performed if IGRA is not available. A PPD ≥10 mm (≥5 mm if receiving ≥15 mg\u002Fday prednisone or other immunosuppressant) is considered positive. Participants with a positive PPD are excluded unless they have completed treatment as above.\n\nFurther exclusion criteria apply.",{"count":204,"type":21},44,[24],"This study is open to healthy people and people with liver problems. Adults between 18 and 80 years can participate. The purpose of this study is to compare how a medicine called BI 3000202 is handled by the body in people with and without liver problems.\n\nAll participants take 1 tablet of BI 3000202. Participants with liver problems may also continue their regular treatment for their liver condition.\n\nParticipants are in the study for about 1 month. During this time, participants visit the study site about 11 times. Where possible, some of these visits may happen by phone. For some visits, participants stay at the study site overnight. Doctors regularly test the amount of BI 3000202 in the blood and check for any health problems.",[56,27],"2026-05-13",{"date":210,"type":34},"2026-05-14",{"date":212,"type":34},"2026-05-01",{"date":214,"type":21},"2027-02-27",{"name":129,"class":41},1,{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100628099","phase-1-radiprodil-in-participants-with-hepatic-impairment-100628099","NCT07457229","Radiprodil in Participants With Hepatic Impairment","Phase 1, Open-Label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Radiprodil in Hepatically Impaired Participants","Inclusion Criteria:\n\n* Male or female participants aged 18 to 75 years, inclusive, at Screening.\n* Body mass index (BMI) within the range specified in the protocol.\n* Participants with hepatic impairment must have stable mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment, as applicable to cohort assignment.\n* Healthy participants must be medically healthy with no clinically significant abnormalities as determined by the investigator.\n* Participants must be willing and able to comply with all study procedures and confinement requirements.\n* Participants of childbearing potential must agree to use highly effective contraception methods as defined in the protocol.\n* Participants must provide written informed consent prior to any study procedures\n\nExclusion Criteria:\n\n* History or presence of clinically significant medical conditions that could interfere with study participation or interpretation of results.\n* Positive test for drugs of abuse, alcohol, or cotinine (where applicable) at Screening or check-in.\n* Positive serology for HIV, hepatitis B surface antigen, or hepatitis C virus.\n* Clinically significant abnormal laboratory values, vital signs, or ECG findings at Screening or Day -1, as judged by the investigator.\n* Use of prohibited concomitant medications or substances that may interfere with radiprodil metabolism.\n* Pregnant or breastfeeding women.\n* Participation in another clinical study or receipt of an investigational product within the protocol-specified timeframe prior to dosing.\n* Any condition that, in the opinion of the investigator or sponsor, would make participation not in the best interest of the participant or could confound study results.",{"count":225,"type":21},40,[24],"This Phase 1, open-label study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of radiprodil in adults with varying degrees of hepatic impairment compared with healthy participants. Radiprodil is being developed as a potential treatment for GRIN-related neurodevelopmental disorders, tuberous sclerosis complex, and focal cortical dysplasia.\n\nApproximately 40 adults aged 18 to 75 years will be enrolled into five cohorts based on liver function (mild, moderate, or severe hepatic impairment) or healthy status. Participants will receive a single 15 mg oral dose of radiprodil and remain in the clinical research unit for intensive PK and safety monitoring through Day 6.\n\nThe primary objective is to characterize the PK profile of radiprodil in participants with hepatic impairment compared with healthy participants. Safety and tolerability will also be assessed. Results from this study will help determine whether dose adjustments are needed in individuals with impaired liver function.",[27],[230,231],"Hepatic impairment","Radiprodil","2026-05-05",{"date":234,"type":34},"2026-05-08",{"date":236,"type":34},"2026-03-03",{"date":238,"type":21},"2027-08",{"name":240,"class":41},"GRIN Therapeutics, Inc.",2,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":241},"100586126","phase-1-study-of-bemnifosbuvirruzasvir-as-a-fixed-dose-combination-in-subjects-with-normal-or-severely-impaired-renal-or-hepatic-function-100586126","NCT06911320","Study of Bemnifosbuvir\u002FRuzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function","A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of Bemnifosbuvir and Ruzasvir Administered as a Fixed-Dose Combination in Adult Participants With Severe Renal or Hepatic Impairment in Comparison to Healthy Participants","Inclusion Criteria:\n\n* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug\n* Females must have a negative pregnancy test at Screening and prior to dosing\n* BMI of 18.5 to 43.0 kg\u002Fm2\n* Willing to comply with the study requirements and to provide written informed consent\n\nRenal Impaired Subjects (Group 1):\n\n* Considered stable in the judgement of an Investigator\n* Presence of severe renal impairment or kidney failure (as defined by eGFR\\\u003C 30 mL\u002F min)\n\nHepatic Impaired Subjects (Group 2):\n\n* Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator\n* Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).\n\nSubjects with Normal Hepatic and Renal Function (Group 3):\n\n* Medically healthy, in the opinion of an Investigator\n* Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Infected with hepatitis B virus, hepatitis C virus or HIV\n* Abuse of alcohol or drugs\n* Use of other investigational drugs within 28 days of dosing\n* Other clinically significant medical conditions or laboratory abnormalities\n\nRenal and Hepatic Impaired Subjects (Group 1 and 2):\n\n* Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c \\> 10%\n* Undergoing any method of dialysis\n* Subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan\n\nRenal Impaired Subjects (Group 1):\n\n* History of renal transplant\n* Concurrent use of medications known to affect the elimination of serum creatinine\n\nHepatic Impaired Subjects (Group 2):\n\n* History of liver transplant\n* Evidence of hepatic carcinoma presence at Screening",{"count":20,"type":21},[24],"To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir\u002FRuzasvir After a Single Dose",[253,27,254],"Healthy Volunteer Study","Renal Impairment","2026-04-08",{"date":257,"type":34},"2026-04-13",{"date":259,"type":34},"2025-04-09",{"date":261,"type":21},"2026-05",{"name":263,"class":41},"Atea Pharmaceuticals, Inc.",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":42},"100573017","phase-1-assessment-of-quizartinib-pharmacokinetic-in-subjects-with-severe-hepatic-impairment-100573017","NCT06740799","Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment","A Phase 1, Multicenter, Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Quizartinib in Subjects With Severe Impaired Hepatic Function","Key Inclusion Criteria:\n\n1. Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.\n2. Male and female subjects 18 to 75 years of age (inclusive), with a body mass index (BMI) of 18 kg\u002Fm2 to 37 kg\u002Fm2 (inclusive) with a minimum body weight of 40 kg at Screening.\n3. In females, documented surgical sterilization (ie, documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure® with hysterosalpingogram \\[documentation to confirm tubal occlusion 12 weeks after procedure\\]), postmenopausal status for at least 1 year (follicle stimulating hormone \\[FSH\\] \\> 40 mIU\u002FmL serum and estradiol \\\u003C40 pg\u002FmL \\[\\\u003C147 pmol\u002FL\\] at Screening), or agreement to have a sterile male partner, or agreement to use 1 of the means of contraception from Screening until 7 months after the dose of quizartinib 4. In females, agreement to not retrieve eggs\u002Fova via assisted reproductive technology (ART) either for their own use or donation while on the study or for 7 months after the last dose of study drug, whichever is later.\n\n5\\. In males, documented surgical sterilization, sexual abstinence, or agreement to use 1 of the means of contraception from Screening until 4 months after the dose of quizartinib 6. In males, agreement to avoid sperm donation for 4 months after the dose of quizartinib\n\nKey Exclusion:\n\n1. Any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality except hepatic impairment) that could interfere with safety, obtaining informed consent, compliance to the study procedures, or the validity of the study results.\n2. In the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib.\n3. Subjects with primary biliary cirrhosis or primary sclerosing cholangitis.\n4. Subjects with history of Gilbert's syndrome.\n5. Presence or history of clinically severe adverse reaction to any drug or known hypersensitivity to any of the ingredients (including inactive ingredients) of quizartinib.\n6. History of stomach or intestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs (with the exception of appendectomy, hernia repair, and\u002For cholecystectomy).",{"count":272,"type":21},12,[24],"This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.",[27],[277],"quizartinib","2026-03-26",{"date":280,"type":34},"2026-04-01",{"date":282,"type":34},"2024-09-30",{"date":284,"type":21},"2026-10-31",{"name":286,"class":41},"Daiichi Sankyo",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":42},"100609820","phase-1-a-study-of-calderasib-mk-1084-in-participants-with-hepatic-impairment-and-healthy-volunteers-mk-1084-017-100609820","NCT07219550","A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)","A Clinical Study to Evaluate the Effect of Hepatic Impairment on the Single-Dose Pharmacokinetics of MK-1084","The main inclusion criteria include but are not limited to:\n\nAll participants:\n\n* Has a body mass index (BMI) between 18.0 and 42.0 kg\u002Fm\\^2\n\nParticipants with hepatic impairment (HI):\n\n* Has a diagnosis of chronic, stable hepatic insufficiency at screening with features of cirrhosis\n\nHealthy volunteers:\n\n* Is medically healthy with no clinically significant medical history\n\nThe main exclusion criteria include but are not limited to:\n\nAll participants:\n\n* Has a history of gastrointestinal disease which may affect food and drug absorption\n* Has a history of cancer (malignancy)\n* Has a positive result for human immunodeficiency virus (HIV)\n* Has had major surgery and\u002For donated or lost significant volume of blood within 56 days prior to dosing\n\nParticipants with HI:\n\n* Has had severe complications of liver disease within the preceding 3 months of screening\n* Has a history of recent (within 3 months prior to screening) variceal bleeds\n* Has evidence of hepatorenal syndrome\n* Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of \\\u003C 3 months\n* Has a history of liver or other solid organ transplantation\n* Has an active infection requiring systemic therapy\n* Requires paracentesis more often than 2 times per month\n* Has transjugular intrahepatic portosystemic shunt and\u002For has undergone portacaval shunting\n* Has received antiviral and\u002For immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to dosing\n* Is using HIV protease inhibitors\n* Is positive for Hepatitis B surface antigen (HBsAg)\n* Is positive for HCV\n\nHealthy volunteers:\n\n* Has positive results for HBsAg or HCV",{"count":295,"type":21},58,[24],"The purpose of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tolerate it.",[56,27],{"date":300,"type":34},"2026-03-05",{"date":302,"type":34},"2025-11-05",{"date":304,"type":21},"2026-08-14",{"name":306,"class":41},"Merck Sharp & Dohme LLC",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":320,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":216},"100442753","phase-1-hepatic-impairment-with-cirrhosis-due-to-cholestatic-liver-disease-100442753","NCT05045482","Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease","A Phase 1, Open-Label Extension Groups Study in Subjects Having Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease","Inclusion Criteria:\n\nFor all subjects:\n\n1. Ability to comprehend and willingness to sign a written ICF for the study.\n2. Male or female aged 18 to 80 years (inclusive) at the time of signing the ICF.\n3. Body mass index within the range 18.0 to 48.0 kg\u002Fm2 (inclusive) at screening.\n4. Females must be non-pregnant, non-lactating and of non-childbearing potential or using highly efficient contraception for the full duration of the study.\n5. Females of child-bearing potential and males must agree to use contraception for the full duration of the study.\n6. Ability to swallow and retain oral medication.\n\n   For Subjects in Groups 8 and 9 (Hepatic impairment group but with cirrhosis from cholestatic liver disease):\n7. Participants having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease in Groups 8 and 9 will be classified in sub groups at screening based on CPT score. If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the hepatology Investigator.\n8. Laboratory test values for hepatic impairment subjects Groups 8 (8A, 8B, 8C) and 9 (9A, 9B, 9C) must be clinically acceptable to the Investigator and meet all the following parameters at Screening:\n\n   1. ALT\u002FAST value ≤ 10 × upper limit of normal (ULN)\n   2. Absolute neutrophil count (ANC) ≥ 750\u002Fmm3\n   3. Platelets ≥ 25,000\u002Fmm3\n   4. Hemoglobin ≥ 8 g\u002FdL\n   5. α-fetoprotein \\\u003C 50 ng\u002FmL or 50-80 ng\u002FmL with negative imaging study (US, CT, MRI).\n\n   For Subjects in Groups 8D and 9D (normal hepatic function groups):\n9. Subjects should be in good health as determined by no clinically significant findings in the medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), or laboratory examinations at Screening or Check-in.\n10. Laboratory test values within normal limits or considered not clinically significant by the Investigator for subjects with normal hepatic function including ALT\u002FAST \\\u003C 1.2 × ULN at screening.\n\nExclusion Criteria:\n\nFor all subjects:\n\n1. Any significant, unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the Investigator or designee.\n2. History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e. basal cell or squamous cell carcinoma).\n3. History of stomach or intestinal surgery or resection within the six months prior to screening that would potentially alter absorption and\u002For excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).\n4. History of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the Investigator.\n5. Any major surgery within 3 months of screening.\n6. Donation of blood or blood products within 3 months prior to screening.\n7. Current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within the two weeks prior to screening.\n8. Use or intend to use any medications\u002Fproducts known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 21 days prior to screening, unless deemed acceptable by the Investigator.\n9. Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.\n10. Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73m2 by modification of diet in renal disease (MDRD) formula at screening.\n11. Positive alcohol breath test at the time of check-in or those subjects who have current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance or subject safety.\n12. Positive test for drugs of abuse at screening or admission. Subjects with a positive test based on a prescribed medication may be enrolled.\n13. Any subject with poor peripheral venous access\n14. Receipt of blood products within 1 month prior to check in.\n15. Human immunodeficiency virus (HIV) type 1 antibody positive at screening for all groups.\n\n    For Subjects in Groups 8 and 9 (Hepatic impairment group but with cirrhosis from cholestatic liver disease):\n16. Other known cause of liver disease such as NASH, alcoholic steatohepatitis (ASH), autoimmune hepatitis, or acute or chronic viral hepatitis as determined by the Investigator and subject's medical records.\n17. Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the participant's medical history and deemed clinically significant by the Investigator.\n18. Subjects having -\n\n    1. History of gastrointestinal bleeding within 1 month prior to screening.\n    2. Current functioning organ transplant.\n    3. Evidence of severe ascites requiring frequent paracentesis in the opinion of investigator.\n19. Subjects who use or intend to use any over the counter (vitamins, minerals, and phytotherapeutic\u002Fherbal\u002Fplant-derived preparations) or prescription medications within 30 days or 5 half-lives (whichever is longer) prior to enrolment, with the exception of hormone replacement therapy and therapies for hepatic disease and treatments of associated disorders that have been stable for at least 30 days prior to screening and until Day 1, unless deemed acceptable by the Investigator (or designee).\n\n    For Subjects in Group 8A (Mild hepatic impairment group) and 8B (Moderate impairment group)\n20. Total bilirubin \\> 5×ULN\n\n    For Control with Normal Hepatic Function:\n21. Subjects who have taken any prescription medications or over-the-counter medications, including herbal products, within 14 days prior to start of study drug dosing, with the exception of vitamins, acetaminophen, hormonal contraceptive medications and\u002For any other over-the-counter product approved by the Investigator.",{"count":99,"type":21},[24],"A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease",[27,318,319],"Cirrhosis","Cholestatic Liver Disease",[27,321,318,319],"Saroglitazar Magnesium","2026-02-13",{"date":324,"type":34},"2026-02-17",{"date":326,"type":34},"2021-10-21",{"date":328,"type":21},"2026-03-31",{"name":330,"class":41},"Zydus Therapeutics Inc.",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":16,"sex":17,"minAge":338,"maxAge":339,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":357},"100383348","phase-1-study-to-evaluate-the-pharmacokinetics-pk-of-e7090-herein-referred-to-as-tasurgratinib-and-its-metabolite-in-participants-with-mild-and-moderate-hepatic-impairment-compared-to-healthy-participants-100383348","NCT04271488","Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants","An Open-label Parallel-Group Study to Evaluate Pharmacokinetics of E7090 and Its Metabolite in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects","Inclusion Criteria:\n\n1. Body mass index (BMI) between 18 to 40 kilogram per square meter (kg\u002Fm\\^2).\n2. For Cohorts A and B: stable hepatic impairment conforming to Child-Pugh classification A and B.\n3. For Cohort C: healthy participants matched to participants with hepatic impairment with regard to age (+\u002F-10 years), body weight (+\u002F-20 percent \\[%\\]), race and gender, and as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations.\n\nExclusion Criteria:\n\nKey Exclusion for all Participants:\n\n1. Following ocular disorders\n\n   1. Current evidence of Grade 2 or higher corneal disorder\n   2. Current evidence of active macular disorder (example, Age-related macular degeneration, central serous chorioretinal disease)\n2. Known to be human immunodeficiency virus (HIV) positive at Screening.\n3. A prolonged QT\u002FQTc interval (\\[QT interval using Fridericia's formula\\] QTcF greater than (\\>) 480 millisecond \\[ms\\]) demonstrated on ECG.\n\nAdditional Exclusion Criteria for Hepatically Impaired Participants (Cohorts A and B)\n\nIn addition to the Exclusion Criteria above for all participants, other standard exclusion criteria for participants with hepatic impairment will be used. These include:\n\n1. Any significant acute medical illness (such as new conditions or exacerbation of pre-existing conditions) within 8 weeks of dosing.\n2. Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy\n3. The participant's standard therapy\u002Fconcomitant medication for diseases related to hepatic disease has not remained stable\u002Funchanged for at least two weeks before dosing of study drug.\n\nAdditional Exclusion Criteria for Healthy participants (Cohort C)\n\nIn addition to the Exclusion Criteria for all participants, other standard exclusion criteria for healthy participants in Phase 1 studies will be used. These include:\n\n1. Syphilis as demonstrated by positive serology at Screening.\n2. Any abnormal finding based on physical examination, assessment of vital signs, ECG, or laboratory test results that requires treatment or clinical follow up based on investigators opinion.","20 Years","79 Years",{"count":341,"type":21},18,[24],"The primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on PK of tasurgratinib after a single dose administration.",[27],[27,346,347],"E7090","Tasurgratinib","2026-01-22",{"date":350,"type":34},"2026-01-23",{"date":352,"type":34},"2020-02-27",{"date":354,"type":21},"2026-11-30",{"name":356,"class":41},"Eisai Co., Ltd.",8,{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":241},"100590047","phase-1-pharmacokinetics-pk-and-safety-of-zanzalintinib-in-participants-with-moderate-hepatic-impairment-hi-100590047","NCT06962332","Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)","A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment","Key Inclusion Criteria:\n\n* All Participants:\n\n  * No clinically significant medical history (aside from the HI for participants in the HI group only), physical examination findings, or vital signs, as deemed by the investigator.\n  * A continuous non-smoker or moderate smoker who smokes ≤ 10 cigarettes, ≤ 2 cigars, or ≤2 pipes per day and agree to limit smoking during the confinement period to ≤ 4 cigarettes or ≤1 cigar or pipe per day. Participant must agree to maintain the same smoking status (smoker or non-smoker) from screening and until after the last PK sample collection.\n  * Has not donated blood within 30 days of dosing or plasma within 7 days of dosing and must agree to refrain from blood donation until at least 30 days following dosing.\n* Participants with Moderate HI Only:\n\n  * Adequate bone marrow function, at the screening and dosing visit.\n  * Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) and has a total bilirubin value within the range of \\> 1.5\\* upper limit of normal (ULN) and ≤ 3\\* ULN at the screening and dosing visit.\n  * Has a diagnosis of chronic (\\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency at the screening visit with features of cirrhosis due to any etiology.\n* Healthy Control Participants Only:\n\n  * Age must be within ± 10 years of the mean age of participants with moderate HI. The sex ratio (male\u002Ffemale ratio), and smoking status ratio (smokers\u002Fnon-smokers ratio) must be the same to the sex and smoking status ratio of participants with moderate HI.\n\nKey Exclusion Criteria:\n\n* All Participants:\n\n  * • History of any medical or surgical conditions that would potentially alter absorption, distribution, metabolism, and\u002For excretion of orally administered drugs.\n  * Has or is at risk for major cardiac events or dysfunction.\n* Participants with Moderate HI Only:\n\n  * History of liver or other solid organ transplant.\n  * Fluctuating or rapidly deteriorating hepatic function (the definition of the change of more than 1 Child-Pugh point) within 30 days prior to Day 1, in the opinion of the investigator and Sponsor.\n  * Symptoms or history of Grade 3 or worse degree of encephalopathy within 3 months of dosing.\n  * Clinical evidence of severe ascites at the screening visit or at check in.\n* Healthy Control Participants Only:\n\n  * History or presence of alcohol or drug abuse within the past 2 years prior to dosing.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":5,"type":21},[24],"The primary purpose of this study is to evaluate the plasma PK of zanzalintinib following a single dose in participants with moderate liver dysfunction compared to matched healthy participants with normal liver function.",[27,369],"Moderate Hepatic Impairment",[371,372],"Zanzalintinib","Pharmacokinetics","2025-06-17",{"date":375,"type":34},"2025-06-22",{"date":377,"type":34},"2025-05-13",{"date":379,"type":21},"2026-04",{"name":381,"class":41},"Exelixis",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":394,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":409},"100476459","phase-1-effect-of-hepatic-impairment-on-the-pharmacokinetics-and-safety-of-vir-2218-and-vir-3434-100476459","NCT05484206","Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434","A Phase 1 Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Monotherapy and Combination Therapy in Adult Participants With Hepatic Impairment","Inclusion Criteria:\n\n* Must be ≥18 to ≤70 years of age at screening\n* Must have a calculated BMI from 18.5 ≤ BMI ≤ 40 kg\u002Fm2\n* All participants must have an eGFR ≥ 60 mL\u002Fmin as calculated by the Modification of Diet in Renal Disease (MDRD) equation\n\nInclusion criteria: Healthy matched participants\n\n* Must in the opinion of the Investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations\n\nInclusion criteria: Hepatic impaired participants\n\n* Apart from hepatic insufficiency, participants must, in the opinion of the Investigator be sufficiently healthy for study participation based on medical history, physical examination, vital signs, and screening laboratory evaluations\n* Participant is considered to have chronic, stable moderate, severe, mild HI (of any etiology excluding chronic HBV and HDV) and has been clinically stable per Investigator assessment for at least 1 month prior to screening\n* CPT score of 5 to 6 for mild HI at screening\n* CPT score 7-9 for moderate HI at screening\n* CPT score 10-15 severe HI at screening\n\nExclusion Criteria:\n\n* Participants with unstable cardiac function or evidence of previous myocardial infarction in the past 12 months or any clinically significant active cardiovascular disease that, in the opinion of the Investigator, could interfere with the safety of the participant\n* Any clinically significant conduction abnormality or arrhythmia (including non-sustained or sustained ventricular tachycardia as per Investigator's assessment)\n* Infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), HBV (positive HBsAg or positive hepatitis B core antibody with negative hepatitis B surface antibody), hepatitis C virus (HCV), HDV or hepatitis E virus (HEV). HCV antibody positive participants with a negative HCV RNA are eligible. HDV antibody positive participants with a negative HDV RNA are eligible\n\nExclusion criteria: Healthy matched participants\n\n* Systolic BP is outside the range of 90-160 mmHg, or diastolic BP is outside the range of 45-95 mmHg or heart rate is outside the range of 50-100 beats per minute (bpm) for female participants or 45-100 bpm for male participants at screening\n* Use of any prescription medications or over-the-counter medications (with the exception of vitamins and\u002For hormonal contraceptive medication) within 30 days prior to D1 of study participation\n\nExclusion criteria: Participants with Hepatic impairment\n\n* Not on stable dose and regimen of any medication\n* Acute or worsening chronic hepatitis\n* Participants requiring paracentesis more than once a month\n* Participants with refractory encephalopathy or significant Central Nervous System\n* History of gastric or esophageal variceal bleeding within the past 6 months\n* Participants with Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement\n* Presence of hepatopulmonary or hepatorenal syndrome\n* Presence of primarily cholestatic liver diseases\n* History of or currently listed for liver transplantation",{"count":390,"type":21},144,[24],"In this study, a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434 will be administered to assess the pharmacokinetic (PK) exposure, safety, and tolerability of VIR-2218 and VIR-3434 in participants with cirrhosis and Hepatic Impairment, defined using the Child-Pugh-Turcotte (CPT) categorization.",[27,318],[395,396,397,398,399],"siRNA","Monoclonal antibody","HDV","Compensated Cirrhosis","Decompensated Cirrhosis","2025-06-10",{"date":402,"type":34},"2025-06-13",{"date":404,"type":34},"2022-09-21",{"date":406,"type":21},"2027-04-30",{"name":408,"class":41},"Vir Biotechnology, Inc.",5,{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":417,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":421,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":429,"locationsCount":216},"100591837","phase-1-a-study-of-hdm1002-in-subjects-with-and-without-varying-degrees-of-hepatic-impairement-100591837","NCT06985615","A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement","A Multi-center, Parallel Cohort, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of HDM1002 in Subjects With Normal Hepatic Function and Hepatic Impairment.","Inclusion Criteria:\n\n1. Age and Sex: Chinese subjects aged 18-70 years (inclusive) at screening, regardless of gender. The normal hepatic function group and hepatic impairment group must be age-matched within ±10 years, with gender matching as close as possible (±1 subject per gender).\n2. Body Weight and Body Mass Index (BMI): At screening, male subjects must weigh ≥50.0 kg, and female subjects ≥40.0 kg, with a BMI ranging from 19.0 to 32.0 kg\u002Fm² (inclusive).The normal hepatic function group and hepatic impairment group must be weight-matched within ±10 kg.\n\nExclusion Criteria:\n\n1. History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2; or serum calcitonin ≥50 ng\u002FL at screening.\n2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to signing the informed consent form (ICF).\n3. History of acute gallbladder disease within 3 months prior to signing the ICF.\n4. History of Malignancy: Diagnosis of any malignancy within 5 years prior to ICF signing (except basal cell carcinoma treated with curative intent and deemed cured).\n5. Severe Systemic Diseases: History of severe cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, or other systemic diseases (e.g., acute myocardial infarction, severe depression, gastric ulcer, uremia) within 1 year prior to ICF signing.\n6. Conditions Affecting Drug Pharmacokinetics: Presence of dysphagia or any condition that, on the investigator's judgment, may impact drug absorption, distribution, metabolism, or excretion (e.g., active inflammatory bowel disease, gastrectomy, intestinal resection) at screening.\n7. Severe Hypoglycemia: Episode of severe hypoglycemia within 3 months prior to screening.\n8. Allergy or Intolerance: History of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis) or known intolerance\u002Fallergy to glucagon-like peptide-1 receptor (GLP-1R) agonists.\n9. Hepatic Function Normal Group Exclusions:a) History of chronic liver disease, including hepatitis, hepatitis B, or hepatitis C, or positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (anti-HCV) at screening.b) Positive Treponema pallidum antibody.c) Use of any medication within 28 days or 5 elimination half-lives (whichever is longer) prior to the first study drug administration.\n10. Hepatic Impairment Group Exclusions:a) Hepatocellular carcinoma, hepatorenal syndrome, or limited life expectancy (defined as \\\u003C1 year for the hepatic impairment cohort).b) Cirrhosis complications (e.g., gastrointestinal bleeding, severe hypoglycemia) within 3 months prior to screening.c) Use of any medication within 7 days or 5 half-lives (whichever is longer) prior to the first study drug administration that may affect HDM1002 pharmacokinetics (PK).",{"count":225,"type":21},[24],"The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002",[27,80],[422],"HDM1002","2025-05-15",{"date":425,"type":34},"2025-05-22",{"date":427,"type":34},"2025-03-18",{"date":210,"type":21},{"name":430,"class":41},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.",{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":216},"100560459","phase-1-a-study-of-ray1225-in-participants-with-impaired-liver-function-100560459","NCT06577415","A Study of RAY1225 in Participants With Impaired Liver Function","A Single Dose Pharmacokinetic Study of ray1225 in Subjects With Varying Degrees of Hepatic Impairment","Inclusion Criteria:\n\n1. Participant must be ≥ 18 to ≤ 75 years;\n2. BMI ≥ 20 kg\u002Fm2 up to ≤ 32 kg\u002Fm2;\n3. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product;\n4. Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment;\n5. eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2;\n\n   Participants with Normal Hepatic Function Only:\n6. Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function;\n\n   Participants with hepatic impairment only:\n7. Males or females with chronic mild and moderate liver impairment, assessed by Child-Pugh scoring.\n\nExclusion Criteria:\n\n1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product;\n2. QTcF\\> 450ms;\n3. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks;\n4. Participates who donated blood or bleeding profusely (\\> 400 mL) in the 3 months;\n5. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test;\n6. Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening;\n7. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;\n\n   Participants with Normal Hepatic Function Only:\n8. Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.\n\n   Participants with Hepatic Impairment Only:\n9. Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders.\n10. Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices.",{"count":76,"type":21},[24],"The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.",[27],{"date":443,"type":34},"2025-03-19",{"date":445,"type":34},"2024-08-26",{"date":447,"type":21},"2025-11-15",{"name":449,"class":41},"Guangdong Raynovent Biotech Co., Ltd",{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":461,"conditions":462,"keywords":463,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":216},"100332304","phase-1-mdma-in-subjects-with-moderate-hepatic-impairment-and-subjects-with-normal-hepatic-function-100332304","NCT03606538","MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function","A Phase I, Open Label, Study of 3,4-Methylenedioxymethamphetamine (MDMA) Tolerability and Pharmacokinetics in Subjects With Moderate Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function","Inclusion Criteria:\n\n* Participants with moderate hepatic impairment (class B according to Child- Pugh's criteria).\n* Participants with normal hepatic function: no clinically significant findings from medical history, physical examination, laboratory values within protocol defined parameters.\n* Age 18 to 65 years.\n* Weight \\> 45 kg\n* Negative Carbohydrate Deficient Transferrin blood test at Screening and negative breathalyzer alcohol test prior to trial drug administration.\n* Negative urine test for drugs of abuse at Screening and prior to trial drug administration.\n* Able to comprehend and willing to sign an informed consent form.\n\nExclusion Criteria:\n\n* Have a current psychiatric diagnosis.\n* Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control.\n* Have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and\u002For laboratory signs of hepatic impairment within 2 weeks.\n* Have autoimmune liver disease; esophageal variceal bleeding within 6 months prior to screening, unless successfully treated with banding, or gastric varices.\n* Have spontaneous bacterial peritonitis within 3 months prior to screening.\n* Have a portosystemic shunt, organ transplant, Wilson's disease, cholestatic liver disease (e g, primary biliary cirrhosis or primary sclerosing cholangitis)\n* Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular (including controlled hyper-tension), coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration.\n* For moderate hepatic impairment participants: have clinically significant laboratory findings except as related to hepatic impairment.\n* For control participants only: have clinically significant laboratory results outside the normal limits, including AST \\>48 U\u002FL, ALT \\> 55 U\u002FL, GGT \\> 48 U\u002FL, bilirubin \\> 1.2 mg\u002FdL or hemoglobin \\\u003C 12 g\u002FdL.\n* Have a history of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject.\n* Have any positive test for drugs of abuse and \u002For alcohol at screening.\n* Have a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of \\> 450 ms in men, \\> 470 ms in women on the screening ECG.\n* Have a PR interval \\> 240 ms, QRS \\> 110 ms or a history of prolongation of QT interval.\n* Have mental incapacity, unwillingness or language barriers precluding adequate understanding or subject co-operation.\n* Are unwilling to stay in the clinical unit for the required duration as per the protocol.\n* Have a known or suspected allergy to trial product or related products.","65 Years",{"count":459,"type":21},16,[24],"The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function.\n\nThe main questions it aims to answer are:\n\nDo people with abnormal liver function experience greater absorption of MDMA? Does the dose of MDMA need to be adjusted in people with abnormal liver function?\n\nResearchers will compare people with abnormal liver function to people with normal liver function.\n\nParticipants will receive a single dose of MDMA then undergo periodic vitals measurements. They will remain at the study site for two more days undergoing more vitals measurements and having subjective effects and adverse events measured.",[372,27],[464,465,466,467],"MDMA","metabolism","methylenedioxymethamphetamine","midomafetamine","2024-10-28",{"date":470,"type":34},"2024-10-30",{"date":472,"type":21},"2026-03-29",{"date":474,"type":21},"2028-12",{"name":476,"class":41},"Resilient Pharmaceuticals"]