[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shionogi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":187},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,79,103,128,154],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100609437","phase-2-a-study-of-s-337395-in-symptomatic-nonhospitalized-adults-with-respiratory-syncytial-virus-rsv-who-are-at-high-risk-of-progression-to-severe-disease-100609437",false,"NCT07214571","A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease","A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus Who Are at High Risk of Progression to Severe Disease","Key Inclusion Criteria:\n\n* Participants who have new onset or worsening (if present chronically) of at least 1 of the following signs and\u002For symptoms consistent with a viral acute respiratory infection within 72 hours prior to randomization: fever, nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing.\n* Participants diagnosed with RSV infection preferably using a rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay.\n* Has at least 1 of the following risk factors for severe RSV disease:\n\n  1. ≥ 75 years of age;\n  2. Chronic lung disease that is symptomatic and requiring chronic treatment; and\n  3. Chronic cardiovascular disease that is symptomatic and requiring chronic treatment.\n* With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening.\n\nKey Exclusion Criteria:\n\n* Hospitalized or expected to be hospitalized within 24 hours of screening.\n* Is considered by the investigator to be immunocompromised, due to an underlying medical condition or medical therapy, chemotherapy, radiation, stem cell or solid organ transplant.\n* Has known allergies, hypersensitivity, or intolerance to S-337395 or to any of the excipients of the S-337395 or placebo formulation.\n* Suspicion or known severe renal impairment.\n* Any other medical or psychiatric condition making the participant unsuitable for the current study or interfering with the evaluation of response to the study intervention in the opinion of the investigator\u002Fsubinvestigator.\n* Has received a therapy intended to treat RSV infection within 14 days prior to screening.\n* Is receiving chemotherapy or immunotherapy for malignancy.\n* Has received RSV vaccination within 7 days prior to screening.\n* Has had either confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza infection (test was positive) during the 28 days prior to screening.\n* Has any other confirmed clinically relevant respiratory infection by any pathogen at, or within 28 days of screening.\n\nNote: Other protocol-specified inclusion and exclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},192,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants with high-risk factors for progression to severe RSV infection starting intervention within 72 hours of RSV symptom onset.",[26],"Respiratory Syncytial Virus Infections",[26,28,29,30,31],"RSV infection","Viral infection","S-337395","Acute lower respiratory tract infection","RECRUITING","2026-06-19",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":36},"2025-12-11",{"date":40,"type":20},"2026-12-30",{"name":42,"class":43},"Shionogi","INDUSTRY",77,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100602411","phase-2-study-of-s-606001-as-an-add-on-to-enzyme-replacement-therapy-ert-in-participants-with-late-onset-pompe-disease-lopd-100602411","NCT07123155","Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD)","A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Investigate the Safety, Pharmacodynamics, and Preliminary Efficacy of S-606001 as an Add-on to Enzyme Replacement Therapy in Patients With Late-onset Pompe Disease","Key Inclusion Criteria:\n\n* Participant must be ≥18 years of age and ≥40 kilograms (kg) of body weight at the time of signing the informed consent.\n* Participant must have a diagnosis of LOPD based on documentation of 1 of the following:\n\n  1. Deficiency of acid alpha-glucosidase (GAA) enzyme\n  2. GAA genotype\n* Participant has a %FVC ≥30% and ≤80% in an upright position without mechanical ventilation at screening; or Participant has ≥10% %FVC drop from upright position to supine position and %FVC ≥20% in a supine position.\n* Participant performs the 6MWT at screening, as determined by the clinical evaluator, and meets all of the following criteria:\n\n  1. Screening values of 6-minute walk distance (6MWD) are ≥75 meters\n  2. Screening values of 6MWD are ≤90% of the predicted value for healthy adults\n* Participants must be ERT-experienced, defined as currently receiving ERT and having been receiving ERT for ≥24 months, with no regimen change in the last 6 months.\n\nKey Exclusion Criteria:\n\n* Has a medical condition or any other extenuating circumstance that may pose an undue safety risk to the participant or may compromise his\u002Fher ability to comply with or adversely impact protocol requirements.\n* Has active infections at screening.\n* Malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n* Current or chronic history of liver disease.\n* Known biallelic loss of function mutations whether in glycogenin gene (GYG) or in glycogen phosphorylase muscle associated gene(PYGM) .\n* Has received any investigational therapy or pharmacological treatment for Pompe disease, within 30 days or 5 half-lives of the therapy or treatment, whichever is longer, before day 1 or is anticipated to do so during the study.\n* Has received gene therapy or small interfering ribonucleic acid (RNA) therapy for Pompe disease.\n* Participant, if female, is pregnant or breastfeeding at screening.\n* Participant, whether male or female, is planning to conceive a child during the study.\n\nNote: Other protocol-specified inclusion and exclusion criteria may apply.",{"count":53,"type":20},45,[23],"The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and exploratory clinical efficacy of S-606001 in adult participants with LOPD as an add-on to ERT.",[57],"Pompe Disease",[59,60,61,62,63,64,65,66,67,68,69,70,71],"Late-onset Pompe disease","Enzyme replacement therapy","LOPD","ERT","S-606001","Muscle glycogen synthase","Liver glycogen synthase","Rare disease","Autosomal disease","Acid alpha-glucosidase","GAA","Glycogen storage disorder","GSD",{"date":35,"type":36},{"date":74,"type":36},"2025-10-30",{"date":76,"type":20},"2027-08-08",{"name":42,"class":43},28,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":17,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100484459","phase-1-safety-and-pharmacokinetics-study-of-naldemedine-in-paediatric-participants-receiving-opioids-100484459","NCT05588323","Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids","A Phase 1\u002F2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment With Opioids","Inclusion Criteria:\n\nDisease Characteristics\n\n* Participants with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids.\n* Participants with either newly diagnosed constipation, a history of constipation treated with laxatives, or are expected to develop constipation after opioid treatment.\n* Able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and are able to return for blood sampling at the 24-hour time point.\n\nWeight\n\n* Body mass index within approximately the 3rd to 97th percentile for their age according to the World Health Organization Child Growth Standards.\n\nExclusion Criteria:\n\nMedical Conditions\n\n* History of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or any recent (within last 1 year) or planned GI tract surgery.\n* Signs or symptoms of GI obstruction or participants with recurrent obstruction who may be at increased risk of GI perforation.\n* Inability to eat\u002Fswallow or have need of a nasogastric tube.\n* No bowel movements reported for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1).\n* History of more than 1 week of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 neutropenia or thrombocytopenia with clinical sequelae.\n* Participants who need mechanical ventilation.\n* Severe CTCAE Grade 3 or above hepatic or renal impairment including end-stage renal disease requiring hemodialysis, as determined by the investigator.\n* Progressive neurological disorders or potential disruption to the blood-brain barrier (for example, primary brain malignancies, central nervous system metastases, active multiple sclerosis, etc.) considering the risk of opioid withdrawal or reduced analgesia.\n\nPrior\u002FOngoing Medications\n\n* Currently receiving the first cycle of chemotherapy.\n* Previously received naldemedine.\n\nOther Exclusions\n\n\\- Positive pregnancy test for females of childbearing potential.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.","2 Years",{"count":88,"type":20},24,[90,23],"PHASE1","The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.",[93],"Opioid-Induced Constipation (OIC)","2026-04-23",{"date":96,"type":36},"2026-04-29",{"date":98,"type":36},"2023-01-04",{"date":100,"type":20},"2026-06-15",{"name":42,"class":43},16,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100447025","phase-1-s-531011-as-monotherapy-and-in-combination-with-an-immune-checkpoint-inhibitor-in-advanced-or-metastatic-solid-tumors-100447025","NCT05101070","S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors","A Phase 1b\u002F2, Multicenter, Open-label Study of S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors","aCCeleR8-001","Eligibility Criteria: Key Inclusion Criteria:\n\n1. Participants with histologically or cytologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors who have no standard therapies with a proven clinical benefit, or who are intolerant to or unwilling to receive these therapies for any reasons.\n2. Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1.\n3. (Part A only) Participants should have 1 of the following tumor types: malignant melanoma, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, non-small cell lung cancer, or triple-negative breast cancer, esophageal cancer (esophageal squamous cell carcinoma and adenocarcinoma), or gastric cancer (gastric and gastroesophageal junction adenocarcinoma). Participants with colorectal cancer (CRC), pancreatic cancer, cervical cancer, epithelial ovarian cancer, and other types of solid tumors may also be enrolled upon discussion with and approval by the sponsor. For the backfill cohorts only, specific tumor types may be selected.\n4. (Part B CRC cohorts only) Participants must have histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum, who had disease progression on or after receiving all of the following standard of care systemic therapies for advanced or metastatic disease or who were intolerant to: fluoropyrimidine, oxaliplatin, and irinotecan; anti-epidermal growth factor receptor (EGFR) therapy if rat sarcoma virus (RAS) (Kirsten RAS\u002Fneuroblastoma RAS \\[KRAS\u002FNRAS\\]) wild-type and medically appropriate ; V-raf murine sarcoma viral oncogene homolog B (BRAF) inhibitor if BRAF V600E mutation. In addition, participants who received up to 2 additional lines of therapy for advanced or metastatic disease of the following therapies are also eligible: trifluridine\u002Ftipiracil, regorafenib, fruquintinib, other drugs approved in the country, or investigational drugs.\n5. (Part C CRC cohorts only) Participants must have histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum, who had disease progression on or after receiving all of the following standard of care systemic therapies for advanced or metastatic disease or who were intolerant to: fluoropyrimidine, oxaliplatin, and irinotecan; anti-EGFR therapy if RAS (KRAS\u002FNRAS) wild-type and medically appropriate ; BRAF inhibitor if BRAF V600E mutation. In addition, participants who received up to 2 additional lines of therapy for advanced or metastatic disease of the following therapies are also eligible: trifluridine\u002Ftipiracil, regorafenib, fruquintinib, other drugs approved in the country, or investigational drugs.\n6. (Parts D and E) Participants must have histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum, who had disease progression on or after receiving all of the following standard of care systemic therapies for advanced or metastatic disease or who were intolerant to: fluoropyrimidine, oxaliplatin, and irinotecan; anti-EGFR therapy if RAS (KRAS\u002FNRAS) wild-type and medically appropriate; BRAF inhibitor if BRAF-V600E mutation.. In addition, participants who received up to 2 additional lines of therapy for advanced or metastatic disease of the following therapies are also eligible: trifluridine\u002Ftipiracil, regorafenib, fruquintinib, other drugs approved in the country, or investigational drugs.\n7. Participants should be willing and able to provide permission to access archival formalin-fixed paraffin-embedded tumor tissues (as block or unstained slides) for this study.\n8. Participants should be willing and able to provide both pre-treatment and on-treatment paired tumor biopsy samples.\n9. (Part A and B\u002FCRC Cohorts only; At selected sites only) Participants should be willing and able to provide both pre-treatment and on-treatment paired tumor biopsy samples. Fresh tissue samples are required as these will be used for the proof of mechanism (flow cytometry) analysis.\n10. Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n11. An estimated life expectancy of at least 12 weeks.\n12. Adequate hematologic and organ function as confirmed by laboratory values.\n13. QT interval corrected with the Fridericia formula ≤ 480 milliseconds in 12- lead electrocardiogram at Screening.\n\nKey Exclusion Criteria:\n\n1. Presence or history of autoimmune diseases or immune-mediated diseases that require chronic use of systemic corticosteroids (\\> 10 milligrams of prednisone equivalent per day), immunosuppressive agents, or disease-modifying agents.\n2. Presence or history of interstitial lung disease and (non-infectious) pneumonitis that required corticosteroids.\n3. Active clinically significant bacterial, viral or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks before the first dose of study intervention.\n4. Uncontrolled or clinically significant cardiovascular disease defined as New York Heart Association classification III or IV.\n5. A positive test for hepatitis B surface antigen and\u002For hepatitis C virus (HCV) antibody (participants with positive HCV antibody are eligible if a confirmatory HCV RNA test is undetectable).\n6. A positive serological test for human immunodeficiency virus infection.\n7. Known history of any other relevant congenital or acquired immunodeficiency.\n8. Known history of an allogeneic tissue and\u002For solid organ transplant.\n9. Known history of severe allergy, hypersensitivity, anaphylaxis, or any serious adverse reaction to any component of study intervention or formulation components and\u002For any other monoclonal antibodies.\n10. Women who are pregnant or breastfeeding (or have discontinued breastfeeding) or trying to become pregnant.\n11. (Parts D and E only) Serious non-healing wound, non-healing ulcer, or non healing bone fracture.\n12. (Parts D and E only) Presence or history of severe arterial thromboembolic events (for example, cerebral infarction, transient ischemic attacks, myocardial infarction, and angina) within 6 months prior to the first dose of study intervention, and\u002For ≥ Grade 3 venous thromboembolic events (for example, deep vein thrombosis) within 3 months prior to the first dose of study intervention. Participants who receive a full-dose therapeutic anticoagulation should be excluded.\n13. (Parts D and E only) Known coagulopathy that increases risk of bleeding, bleeding diatheses, or any other hemorrhage\u002Fbleeding event of ≥ Grade 3 within 4 weeks prior to the first dose of study intervention.\n14. (Parts D and E only) Presence or history of any life-threatening vascular endothelial growth factor (VEGF)-related adverse event (AE).\n15. (Parts D and E only) Proteinuria ≥ 2+ by urine dipstick test within 4 weeks prior to the first dose of study intervention.\n16. Clinical evidence of uncontrolled brain metastasis.\n17. Clinically uncontrollable symptomatic pleural effusion and\u002For ascites. (Participants who do not require fluid drainage or have no significant increase of fluid for 28 days may be eligible with approval by the sponsor.)\n18. Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n19. (Part B, C, D and E CRC cohorts only): Colorectal cancer with mismatch repair deficient\u002Fmicrosatellite instability-high status.\n20. (Parts A-2, C and E only): Has received prior therapy with an anti-programmed death 1, anti-programmed death ligand 1, or anti-programmed death ligand 2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (for example, cytotoxic T-lymphocyte-associated protein 4, OX-40, CD137), and was discontinued from that treatment due to ≥ Grade 3 immune-related adverse event.\n21. Prior treatment with systemic anticancer drugs (including any investigational medicinal products) within 28 days or 5 half-lives (whichever is shorter) before the first dose of study intervention.\n22. Prior major surgery within 28 days before the first dose of study intervention.\n23. Prior extended field radiotherapy within 28 days before the first dose of study intervention (within 14 days for limited field radiation for palliation) or history of radiation pneumonitis.\n24. Participants who have not recovered from any previous treatment toxicities to ≤ Grade 1 or baseline (except alopecia and peripheral neuropathy) before the first dose of study intervention.\n25. Prior treatment with anti-CCR8 antibody for any indication.\n26. Receipt of hematopoietic growth factors (for example, granulocyte-colony stimulating factor or erythropoietin) within 14 days before the first dose of study intervention or blood transfusions within 14 days before the first dose of study intervention.\n27. (Parts D and E only) Presence or history of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.\n28. (Parts D and E only) Presence or history of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.\n29. Receipt of a live, attenuated vaccine within 30 days before the first dose of study intervention.\n\nNote: Additional protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":112,"type":20},282,[90,23],"The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D) of S-531011 with or without pembrolizumab.\n\nThe primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D with or without pembrolizumab.\n\nThe primary objective of Parts D and E is to evaluate the antitumor activity of S-531011 at the RP2D in combination with bevacizumab with our without pembrolizumab.",[116],"Solid Tumors",[118],"C-C motif chemokine receptor 8 (CCR8)","2026-03-16",{"date":121,"type":36},"2026-03-18",{"date":123,"type":36},"2022-05-30",{"date":125,"type":20},"2028-05-31",{"name":42,"class":43},8,{"id":129,"slug":4,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100609692","NCT07217886","A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls","A Phase 1, Multicenter, Nonrandomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of S-892216-PO in Participants With Varying Degrees of Renal Impairment and Matched Control Participants With Normal Renal Function","Key Inclusion Criteria:\n\n* Considered to be healthy (for normal renal function participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram during the screening period and on Day -1.\n* Participants With Severe, Moderate, and Mild Renal Impairment not on HD (Group A, D and E): Participants that are not undergoing HD and have mild, moderate, or severe renal impairment based upon the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula (estimated glomerular filtration rate \\[eGFR\\]) and the participant's body surface area (BSA) calculated at the screening visit.\n* Participants With Renal Impairment Requiring HD (Group B): Receiving stable HD at least 3 times a week for at least 6 months prior to screening\n* Participants With Normal Renal Function: Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by the 2021 CKD-EPI creatinine formula and the participant's BSA, must be normal (that is, eGFR ≥90 milliliters\u002Fminute).\n\nKey Exclusion Criteria:\n\n* Participants with life expectancy less than or equal to 3 months.\n* History or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data based on the judgment of the investigator.\n* Participants With Normal Renal Function: History or presence of renal disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.\n* Participants With Any Renal Impairment (Groups A, B, D, and E): Participant with clinically significant laboratory values in the opinion of the investigator or outside protocol-specified ranges or limits during the screening period or on Day -1.\n* Participants With Severe, Moderate, Mild Renal Impairment not on HD (Groups A, D, and E): Current or anticipated need for HD during the study.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",true,"80 Years",{"count":137,"type":20},40,[90],"The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or renal impairment requiring hemodialysis (HD), and in participants with normal renal function.",[141],"Renal Impairment",[143,144,145],"S-892216","Hemodialysis","Pharmacokinetics","2025-10-28",{"date":74,"type":36},{"date":149,"type":36},"2025-10-16",{"date":151,"type":20},"2026-06-05",{"name":42,"class":43},4,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":134,"sex":161,"minAge":17,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},"100600137","phase-1-study-of-s-892216-long-acting-injectable-lai-in-healthy-adult-participants-100600137","NCT07093580","Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants","Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants","Key Inclusion Criteria:\n\n* Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)\u002Fsquare meter (m\\^2)\n\nKey Exclusion Criteria:\n\n* Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (for example, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment.\n* History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n* Require medication or other treatment (for example, dietary restrictions or physical therapy).\n* Participated in any other clinical study involving an investigational study intervention or any other type of medical research within 30 days, or 5 times the half-life of the investigational drug, before signing of the informed consent form (ICF) for this study or who are currently participating in such a study.\n* Positive test results of the following at screening or within 6 months prior to administration of study intervention: hepatitis B surface antigen (HBsAg); hepatitis C virus antibody (HCV); and human immunodeficiency virus (HIV) antigen\u002Fantibody.\n* Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) test result, positive transcription-mediated amplification test result, positive antigen test result, or any other test approved according to local regulations at check in for each period on admission.\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of S-892216-LAI or placebo for S-892216-LAI.\n* Used cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","MALE","55 Years",{"count":164,"type":20},98,[90],"The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.",[168],"Healthy Participants",[170,171,143,172,173,174,175,176,177],"First-in-human (FIH)","Long-acting injectable (LAI) formulation","S-892216-LAI","Severe acute respiratory syndrome coronavirus 2","SARS-CoV-2 infection","Novel Coronavirus","Coronavirus Disease 2019","COVID-19","2025-08-20",{"date":180,"type":36},"2025-08-27",{"date":182,"type":36},"2025-07-29",{"date":184,"type":20},"2027-05-26",{"name":42,"class":43},2,""]