Clinical Trial: Pharmacokinetics of Eleclazine in Adults With Normal and Impaired Hepatic Function

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Open-Label, Parallel-Group, Adaptive, Single Dose Study to Evaluate the Pharmacokinetics of GS-6615 in Subjects With Normal and Impaired Hepatic Function

Brief Summary: This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of eleclazine in participants with normal and impaired hepatic function. Participants in the healthy control group will be matched to participants with impaired hepatic function by age (± 5 years), gender, and body mass index (± 10%).

Detailed Summary:
Sponsor: Gilead Sciences

Current Primary Outcome:

  • PK Parameter: AUC_0-inf of eleclazine and its metabolite GS-623134 [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours, 15, 29, 43, and 57 days postdose ]
    AUC_0-inf is defined as the concentration of drug over time from time zero to infinity.
  • PK Parameter: Cmax of eleclazine and its metabolite GS-623134 [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours, 15, 29, 43, and 57 days postdose ]
    Cmax is defined as the maximum concentration of drug.


Original Primary Outcome: Plasma pharmacokinetics (PK) profiles of GS-6615 and its metabolite GS-623134: AUC_0-inf and Cmax [ Time Frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours, 15, 29, 43, and 57 days postdose on Day 1 ]

This endpoint will measure the plasma PK profiles of GS-6615 and GS-623134. PK parameters that will be measured include AUC_0-inf and Cmax.


Current Secondary Outcome:

  • Incidence of adverse events [ Time Frame: Up to 58 days ]
  • Proportion of participants with laboratory abnormalities [ Time Frame: Up to 58 days ]


Original Secondary Outcome: Safety profile of GS-6615 as measured by incidence of adverse events and laboratory abnormalities [ Time Frame: Up to 58 days ]

Information By: Gilead Sciences

Dates:
Date Received: March 11, 2015
Date Started: March 2015
Date Completion:
Last Updated: April 27, 2016
Last Verified: April 2016