[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659016":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":11,"studyPopulation":11,"armGroups":33,"interventions":48,"overallOfficials":11,"centralContacts":56,"locations":62,"responsibleParty":85,"collaborators":11,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":11,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":11,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":108,"whyStopped":11,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},{"fullName":5,"class":6},"Shionogi Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":11},[9,13,15,17,19,21],{"measure":10,"description":11,"timeFrame":12},"Maximum Observed Plasma Concentration (Cmax) of Sulthiame",null,"0 (predose) up to 168 hours postdose (Day 1 up to Day 8)",{"measure":14,"description":11,"timeFrame":12},"Time to Reach Cmax (Tmax) of Sulthiame",{"measure":16,"description":11,"timeFrame":12},"Area Under the Plasma Concentration-time Curve Extrapolated From Time 0 to the time of the Last Quantifiable Concentration After Dosing (AUC0-last) of Sulthiame",{"measure":18,"description":11,"timeFrame":12},"Cmax of Sulthiame Metabolite",{"measure":20,"description":11,"timeFrame":12},"Tmax of Sulthiame Metabolite",{"measure":22,"description":11,"timeFrame":12},"AUC0-last of Sulthiame Metabolite",[24],{"measure":25,"description":11,"timeFrame":26},"Number of Participants With Treatment-emergent Adverse Events (TEAEs)","Day 1 up to Day 15",{"allocation":28,"interventionModel":29,"interventionModelDescription":11,"primaryPurpose":30,"observationalModel":11,"timePerspective":11,"maskingInfo":31},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":11,"whoMasked":11},"NONE",[34,40,44],{"label":35,"type":36,"description":37,"interventionNames":38},"Group A: Participants with Mild Renal Impairment","EXPERIMENTAL","Participants with mild renal impairment will receive a single dose of sulthiame in the fasted state on Day 1.",[39],"Drug: Sulthiame",{"label":41,"type":36,"description":42,"interventionNames":43},"Group B: Participants with Moderate Renal Impairment","Participants with moderate renal impairment will receive a single dose of sulthiame in the fasted state on Day 1.",[39],{"label":45,"type":36,"description":46,"interventionNames":47},"Group C: Healthy Participants With Normal Renal Function","Healthy participants with normal renal function will receive a single dose of sulthiame in the fasted state on Day 1.",[39],[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DRUG","Sulthiame","Tablet for oral administration",[35,41,45],[55],"S-054502",[57],{"name":58,"role":59,"phone":60,"phoneExt":11,"email":61},"Shionogi Clinical Trials Administrator Clinical Support Help Line","CONTACT","1-800-849-9707","Shionogiclintrials-admin@shionogi.co.jp",[63,76],{"facility":64,"status":11,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":11},"Omega Research Orlando, LLC","Altamonte Springs","Florida","32714","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-81.36562,28.66111,{"lat":74,"lon":73},{"facility":77,"status":11,"city":78,"state":66,"zip":79,"country":68,"countryCode":69,"cosmosGeoPoint":80,"geoPoint":84,"contacts":11},"Floridian Clinical Research","Miami Lakes","33016",{"type":71,"coordinates":81},[82,83],-80.30866,25.90871,{"lat":83,"lon":82},{"type":86,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659016","phase-1-study-of-sulthiame-s-054502-in-participants-with-renal-impairment-and-matched-healthy-controls-100659016",false,"NCT07857837","Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls","A Phase 1, Multi-center, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Sulthiame (S-054502) in Participants With Varying Degrees of Renal Impairment and Matched Healthy Control Participants With Normal Renal Function","Key Inclusion Criteria:\n\nAll Participants:\n\n* Participants who are considered to be healthy (for normal renal function participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including previous medical conditions\u002Fconcurrent medical conditions, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiography (ECG) during the screening period and on Day -1. Participants with renal impairment should have no clinically significant changes (based on investigator clinical judgment) in previous medical conditions\u002Fconcurrent medical conditions or laboratory values within 3 months prior to administration of the investigational intervention on Day 1.\n* Body weight ≥ 60 kilograms (kg) for male and ≥ 50 kg for female and body mass index (BMI) within the range 18.5 to 40.0 (inclusive) kg\u002Fsquare meter (m\\^2) .\n\nParticipants With Renal Impairment (Groups A and B):\n\n* Participants who have mild and moderate renal impairment based on estimated glomerular filtration rate (eGFR) calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula and the participant's body surface area (BSA) at the screening visit (Day -28 to -2).\n\n  * Mild renal impairment: 60 to \\\u003C 90 milliliters (mL)\u002Fminute (min)\n  * Moderate renal impairment: 30 to \\\u003C 60 mL\u002Fmin\n* A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of the investigational intervention through the follow-up\u002Fearly termination visit.\n\nHealthy Participants With Normal Renal Function (Group C):\n\n* Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function based on eGFR, calculated based on the 2021 CKD EPI creatinine formula and the participant's BSA, must be normal (eGFR ≥ 90 mL\u002Fmin) at the screening visit.\n* Matched to an individual participant with moderate renal impairment (Group B) with respect to age (± 10 years), body weight (± 10 kg), and sex.\n\nKey Exclusion Criteria:\n\nAll Participants:\n\n* History or presence of\u002Fsignificant history of or current cardiovascular, respiratory, hepatic, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.\n* History of GI surgery such as gastrectomy and enterectomy that could lead to clinically significant gastrointestinal dysfunction.\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).\n* Participants with fluctuating or rapidly deteriorating renal function.\n* Participation in any other clinical study or any other type of medical research involving administration of an investigational intervention (new chemical entity) within 28 days or 5 half-lives of the investigational intervention (if known) prior to dosing, whichever is longer.\n\nParticipants With Renal Impairment (Groups A and B):\n\n* Participant with clinically significant laboratory values in the opinion of the investigator or outside the protocol-defined ranges or limits during the screening period or on Day -1.\n\nHealthy Participants With Normal Renal Function (Group C):\n\n* History or presence of\u002Fsignificant history of or current renal disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.",true,"ALL","18 Years","80 Years",{"count":99,"type":100},30,"ESTIMATED","INTERVENTIONAL",[103],"PHASE1","The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of sulthiame in participants with mild and moderate renal impairment compared to those in healthy participants with normal renal function.",[106],"Renal Impairment",[51,55,106],"NOT_YET_RECRUITING","2026-09-29",{"date":111,"type":112},"2026-10-05","ACTUAL",{"date":109,"type":100},{"date":115,"type":100},"2026-12-11",{"name":117,"class":6},"Shionogi",2]