drugset / Trial / NCT02891408

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

NCT02891408

Phase 1 Completed 74 enrolled Gilead Sciences
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2016-09-23
Primary completion
2019-05-05
Completion
2019-05-13

Publications

  • Results Nelson C, Weber E, Yue MS, Millward V, Qin AR, Marbury TC, et al. The Pharmacokinetics of GS-0976, an Acetyl-CoA Carboxylase (ACC) Inhibitor, in Subjects with Mild, Moderate, and Severe Hepatic Impairment [Abstract 1719]. Hepatology AASLD Abstracts 2018;68 (Suppl 1):979A-80A.

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenofibrate Small molecule 48 mg Oral
Subject Firsocostat Small molecule 5 mg Oral
Subject Firsocostat Small molecule 20 mg Oral