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
Completed
Gilead Sciences
Phase 1
This study will evaluate the safety and tolerability of escalating single- and multiple-oral
doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of
cilofexor. The study will be conducted in 3 parts (Part A, Part B, and Part C). Participants
will receive either cilofexor or cilofexor placebo.
Part A will proceed in 4 prespecified staggered cohorts. Within each cohort, the cumulative,
blinded safety data will be evaluated for dose escalation from single-dose (Period 1) to
multiple-dose (Period 2). Based on the available safety, pharmacokinetics, and/or
pharmacodynamics (PD) data from cohorts in Part A and Part C (if applicable), total daily
doses and frequency of dosing will be chosen for the cohorts in Part B. Parts B and C will
consist of adaptive cohorts and may be initiated in parallel. Part B cohorts may be initiated
in parallel with cohorts in Part A if the total dose under evaluation is at or below a dose
already evaluated.
This study is partially blinded (no one is blinded on Day -1).
Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)
Completed
Gilead Sciences
Phase 2
The primary objective of this study is to evaluate the safety and tolerability of
selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic
fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
Completed
Gilead Sciences
Phase 1
The primary objective of this study is to evaluate the single-dose pharmacokinetics of
cilofexor in adults with impaired hepatic function relative to matched, healthy controls with
normal hepatic function.
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