NCT02891408

Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nonalcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	Firsocostat	Capsule(s) administered orally on Day 1
DRUG	Fenofibrate	Tablet administered orally on Day 1

Timeline

• Start date: 2016-09-23
• Primary completion: 2019-05-05
• Completion: 2019-05-13
• First posted: 2016-09-07
• Last updated: 2020-12-17
• Results posted: 2020-12-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study