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A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

Trial Profile

A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

Completed
Phase of Trial: Phase I

Latest Information Update: 08 Mar 2018

At a glance

  • Drugs Velpatasvir (Primary)
  • Indications Hepatitis C
  • Focus Pharmacokinetics
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 08 Mar 2018 Results assessing pharmacokinetics and safety of Velpatasvir and Sofosbuvir/Velpatasvir in subjects with hepatic impairment in two studies (phase I study of Velpatasvir and a pharmacokinetic sub-study of a phase III study of SOF/VEL-ASTRAL-4), published in Clinical Pharmacokinetics Journal.
    • 28 Aug 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 21 Aug 2013 Planned end date changed from 1 Oct 2013 to 1 Aug 2013 as reported by ClinicalTrials.gov.
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