| Trial ID: | L0311 |
| Source ID: | NCT02891408
|
| Associated Drug: |
Firsocostat
|
| Title: |
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
|
| Acronym: |
HI
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT02891408/results
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: Firsocostat|Drug: Fenofibrate
|
| Outcome Measures: |
Pharmacokinetic (PK) Parameter: AUClast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)|PK Parameter: AUCinf of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)|PK Parameter: Cmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)|PK Parameter: % AUCexp of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)|PK Parameter: Tmax of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)|PK Parameter: Clast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)|PK Parameter: Tlast of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)|PK Parameter: ??z of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)|PK Parameter: CL/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)|PK Parameter: Vz/F of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)|PK Parameter: t1/2 of Firsocostat, GS-834773 (Primary Metabolite of Firsocostat), and Fenofibric Acid (Primary Metabolite of Fenofibrate)|Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)|Percentage of Participants Experiencing Laboratory Abnormalities
|
| Sponsor/Collaborators: |
Gilead Sciences
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
74
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
September 23, 2016
|
| Completion Date: |
May 13, 2019
|
| Results First Posted: |
December 17, 2020
|
| Last Update Posted: |
December 17, 2020
|
| Locations: |
Tustin, California, United States|Miami, Florida, United States|Orlando, Florida, United States|Minneapolis, Minnesota, United States|San Antonio, Texas, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT02891408
|
