At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 74 enrolled
Drug / intervention
Firsocostat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-0976 or Fenofibrate in Subjects With Normal and Impaired Hepatic Function
In Brief
A Phase 1 clinical trial evaluating Firsocostat and Fenofibrate for Nonalcoholic Steatohepatitis (NASH). Completed, enrolled 74 participants across 5 sites.
Detailed Summary
The primary objectives of this study are to evaluate the single-dose pharmacokinetics (PK) of firsocostat in adults with normal hepatic function, and mild, moderate, or severe hepatic impairment and to evaluate the single-dose PK of fenofibrate in adults with normal hepatic function and mild hepatic impairment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonalcoholic Steatohepatitis (NASH)
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartSep 2016
Primary CompletionMay 2019
Study CompletionMay 2019
TodayJul 2026
First PostedSep 7, 2016
Enrollment StartSep 23, 2016
Primary CompletionMay 5, 2019
Study CompletionMay 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.8 years ago
Interventions
Firsocostatdrug
Capsule(s) administered orally on Day 1
Fenofibratedrug
Tablet administered orally on Day 1