[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613646":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":76,"collaborators":32,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":32,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":32,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":32,"overallStatus":45,"whyStopped":32,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: PF-07328948 participants with severe hepatic impairment","EXPERIMENTAL","Participants with severe hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.",[13],"Drug: PF-07328948",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: PF-07328948 participants with moderate hepatic impairment","Participants with moderate hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group 3: PF-07328948 participants with mild hepatic impairment","Participants with mild hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Group 4: PF-07328948 participants without hepatic impairment","Participants without hepatic impairment will receive a single dose of PF-07328948, administered orally as 1 PF-07328948 tablet.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","PF-07328948","PF-07328948, 1 tablet orally, once on Day 1",[9,15,19,23],null,[34],{"name":35,"affiliation":5,"role":36},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},"CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[43,57,67],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":32},"Orange County Research Center","RECRUITING","Lake Forest","California","92630","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-117.68922,33.64697,{"lat":55,"lon":54},{"facility":58,"status":45,"city":59,"state":60,"zip":61,"country":49,"countryCode":50,"cosmosGeoPoint":62,"geoPoint":66,"contacts":32},"Orlando Clinical Research Center","Orlando","Florida","32809",{"type":52,"coordinates":63},[64,65],-81.37924,28.53834,{"lat":65,"lon":64},{"facility":68,"status":45,"city":69,"state":60,"zip":70,"country":49,"countryCode":50,"cosmosGeoPoint":71,"geoPoint":75,"contacts":32},"Genesis Clinical Research, LLC","Tampa","33603",{"type":52,"coordinates":72},[73,74],-82.45843,27.94752,{"lat":74,"lon":73},{"type":77,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","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",false,"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.",true,"ALL","18 Years","74 Years",{"count":90,"type":91},26,"ESTIMATED","INTERVENTIONAL",[94],"PHASE1","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.",[97,98],"Hepatic Impairment","Healthy","2026-05-22",{"date":101,"type":102},"2026-05-26","ACTUAL",{"date":104,"type":102},"2025-12-22",{"date":106,"type":91},"2027-02-23",{"name":5,"class":6},3]