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A Phase 1 Open-Label, Parallel-Group, Two-Treatment, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9674 and GS-0976 in Subjects with Normal Renal Function and Severe Renal Impairment

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Trial Profile

A Phase 1 Open-Label, Parallel-Group, Two-Treatment, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9674 and GS-0976 in Subjects with Normal Renal Function and Severe Renal Impairment

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 Jan 2023

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At a glance

  • Drugs Cilofexor (Primary) ; Firsocostat (Primary)
  • Indications Non-alcoholic steatohepatitis
  • Focus Pharmacokinetics
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 26 Jan 2023 Results assessing to characterize the pharmacokinetics, safety, and tolerability of firsocostat and cilofexor, including their respective nonactive metabolites, in participants with normal renal function and severe renal impairment to inform dosing recommendations in patients with reduced renal function, published in the Journal of Clinical Pharmacology.
    • 15 Nov 2021 Results presented at The Liver Meeting 2021: 72nd Annual Meeting of the American Association for the Study of Liver Diseases
    • 24 Mar 2021 Status changed from recruiting to completed.

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