| Trial ID: | L0313 |
| Source ID: | NCT02654002
|
| Associated Drug: |
Cilofexor
|
| Title: |
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
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT02654002/results
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: Cilofexor|Drug: Placebo
|
| Outcome Measures: |
Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor|Single-Dose PK Parameter: AUCinf of Cilofexor|Single-Dose PK Parameter: Cmax of Cilofexor|Multiple-Dose PK Parameter: AUCtau of Cilofexor|Multiple-Dose PK Parameter: Cmax of Cilofexor|Multiple-Dose PK Parameter: Ctau of Cilofexor|Percentage of Participants With at Least One Adverse Event (AE)|Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities|Percentage of Participants With Clinical Laboratory Abnormalities|Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio|PD Parameter: FGF19 Cmax Ratio|PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio|PD Parameter: C4 Cmin Ratio
|
| Sponsor/Collaborators: |
Gilead Sciences
|
| Gender: |
All
|
| Age: |
18 Years to 45 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
120
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
January 20, 2016
|
| Completion Date: |
July 14, 2016
|
| Results First Posted: |
October 12, 2020
|
| Last Update Posted: |
October 12, 2020
|
| Locations: |
SeaView Research, Inc, Miami, Florida, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT02654002
|
