[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610464":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":22,"studyPopulation":15,"armGroups":23,"interventions":29,"overallOfficials":15,"centralContacts":15,"locations":35,"responsibleParty":56,"collaborators":15,"id":58,"slug":15,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":15,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":38,"whyStopped":15,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Sparrow Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":15},[9,13],{"measure":10,"description":11,"timeFrame":12},"1. Maximum plasma concentration (Cmax)","Conclusions that clofutriben and AS2570469 exposures (separately) are not altered by moderate renal impairment will be reached if the 95% CIs of the geometric mean estimates of AUC0-t, AUC0-inf, and Cmax of clofutriben and AS2570469 fall within the \\[60%, 140%\\] range.","from enrollment through treatment for 6 days.",{"measure":14,"description":11,"timeFrame":12},"2. Area under the plasma time-concentration curve (AUC0-t, AUC0-inf)",null,{"allocation":17,"interventionModel":18,"interventionModelDescription":15,"primaryPurpose":19,"observationalModel":15,"timePerspective":15,"maskingInfo":20},"NA","SINGLE_GROUP","TREATMENT",{"masking":21,"maskingDescription":15,"whoMasked":15},"NONE","Following Screening, enrolled participants will be confined to a clinical research unit for 6 days. Each participant will receive a single oral dose of clofutriben. Clofutriben PK, safety, and tolerability will be assessed. The participants will be contacted by telephone 4 weeks after clofutriben administration for safety follow-up.",[24],{"label":25,"type":26,"description":15,"interventionNames":27},"clofutriben","EXPERIMENTAL",[28],"Drug: 12mg clofutriben",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":15},"DRUG","12mg clofutriben","Each participant will receive a single oral dose of clofutriben",[25],[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Orlando Clinical Research Center","RECRUITING","Orlando","Florida","32809","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-81.37924,28.53834,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":54,"phoneExt":15,"email":55},"Rhyan Clinical Research Manager","CONTACT","407.472.0225","rdumontlorenzo@ocrc.net",{"type":57,"investigatorFullName":15,"investigatorTitle":15,"investigatorAffiliation":15,"oldNameTitle":15,"oldOrganization":15},"SPONSOR","100610464",false,"NCT07227922","Clofutriben Pharmacokinetics in Patients With Impaired Renal Function","RENAL","Inclusion Criteria:\n\n* Male and female participants with stable moderate renal impairment (estimated glomerular filtration rate \\[eGFR\\]: 30 to \\\u003C60 mL\u002Fmin) and matched (by sex, age, and weight) control participants with normal renal function (eGFR: ≥90 mL\u002Fmin) will be enrolled in this trial.\n\nExclusion Criteria:\n\n* Participant whose current or recent medical conditions, medications, or procedures could increase participant's safety risk, or whom the Investigator considers not suitable for entry into the trial or the participant, or who has clinically significant abnormal 12-lead electrocardiogram (ECG)\u002F vital sign measurements\u002F laboratory test results at Screening and Check-in, will not be enrolled",true,"ALL","18 Years","83 Years",{"count":69,"type":70},16,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","This is a Phase 1, single-center, open-label, single-dose trial. Sixteen participants are planned: 8 participants with moderate renal impairment and 8 matched control participants with normal renal function.",[76],"Moderate Renal Impairment",[78],"Renal","2025-12-22",{"date":81,"type":82},"2025-12-23","ACTUAL",{"date":84,"type":82},"2025-11-30",{"date":86,"type":70},"2026-07-01",{"name":5,"class":6},1]