[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100259257":3},{"organization":4,"armGroups":7,"interventions":50,"overallOfficials":62,"centralContacts":61,"locations":66,"responsibleParty":79,"collaborators":61,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":61,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":61,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":61,"overallStatus":100,"whyStopped":61,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,15,19,23,27,31,35,39,43,47],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Cilofexor 10 mg","EXPERIMENTAL","Participants in fasted state will receive cilofexor 10 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg or placebo once daily from Day 7 to Day 20.",[13,14],"Drug: Cilofexor","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort 2: Cilofexor 30 mg","Participants in fasted state will receive cilofexor 30 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 30 mg or placebo once daily from Day 7 to Day 20.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Cohort 3: Cilofexor 100 mg","Participants in fasted state will receive cilofexor 100 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg or placebo once daily from Day 7 to Day 20.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Cohort 4: Cilofexor 300 mg","Participants in fasted state will receive cilofexor 300 mg or placebo once on Day 1 followed by a 5-day washout period then receive cilofexor 300 mg or placebo once daily from Day 7 to Day 20.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Cohort 5: Cilofexor 100 mg","Participants in fed state will receive cilofexor 100 mg or placebo once with food on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg or placebo tablet, orally, once daily with food from Day 7 to Day 20.",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Cohort 6: Cilofexor 50 mg","Participants in fed state will receive cilofexor 50 mg or placebo twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 50 mg or placebo twice daily from Day 7 to Day 20.",[13,14],{"label":36,"type":10,"description":37,"interventionNames":38},"Cohort 7: Cilofexor 15 mg","Participants in fed state will receive cilofexor 15 mg or placebo twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 15 mg or placebo twice daily from Day 7 to Day 20.",[13,14],{"label":40,"type":10,"description":41,"interventionNames":42},"Cohort 8: Cilofexor 10 mg","Participants in fed state will receive cilofexor 10 mg or placebo once with food on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg or placebo once daily from Day 7 to Day 20.",[13,14],{"label":44,"type":10,"description":45,"interventionNames":46},"Cohort 9: Cilofexor","Participants will receive cilofexor up to 300 mg or placebo once daily in the evening on empty stomach.",[13,14],{"label":48,"type":10,"description":45,"interventionNames":49},"Cohort 10: Cilofexor",[13,14],[51,58],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"DRUG","Cilofexor","Tablets administered orally",[48,9,16,20,24,28,32,36,40,44],[57],"GS-9674",{"type":52,"name":59,"description":54,"armGroupLabels":60,"otherNames":61},"Placebo",[48,9,16,20,24,28,32,36,40,44],null,[63],{"name":64,"affiliation":5,"role":65},"Gilead Study Director","STUDY_DIRECTOR",[67],{"facility":68,"status":61,"city":69,"state":70,"zip":61,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":61},"SeaView Research, Inc","Miami","Florida","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-80.19366,25.77427,{"lat":77,"lon":76},{"type":80,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100259257","phase-1-study-in-healthy-volunteers-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-gs-9674-cilofexor-and-the-effect-of-food-on-gs-9674-pharmacokinetics-and-pharmacodynamics-100259257",true,"NCT02654002","Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics","A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674, and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics","Key Inclusion Criteria:\n\n* Healthy male and non-pregnant, non-lactating female volunteers\n* Body mass index (BMI) 19 ≤ BMI ≤ 30 kg\u002Fm\\^2\n* Normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the investigator\n* Normal renal function (estimated glomerular filtration rate calculated using the Cockcroft-Gault equation ≥ 80 mL\u002Fmin)\n* No significant medical history, and in good general health as determined by the investigator at screening evaluation performed no more than 28 days prior to the scheduled first dose.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","45 Years",{"count":92,"type":93},120,"ACTUAL","INTERVENTIONAL",[96],"PHASE1","This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants will receive either cilofexor or cilofexor placebo.\n\nPart A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative, blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and\u002For pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose already evaluated.\n\nThis study is partially blinded (no one is blinded on Day -1).",[99],"Nonalcoholic Steatohepatitis (NASH)","COMPLETED","2020-09-16",{"date":103,"type":93},"2020-10-12",{"date":105,"type":93},"2016-01-20",{"date":107,"type":93},"2016-07-14",{"name":5,"class":6},1]