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

Brief Summary: This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of eleclazine and its metabolite, GS-623134, in participants with normal and impaired renal function. Participants in the healthy control group will be matched to participants with impaired renal function by age (± 5 years), gender, and body mass index (± 10%).

Detailed Summary:
Sponsor: Gilead Sciences

Current Primary Outcome: Plasma pharmacokinetics (PK) profiles of eleclazine 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 ]

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 ]

Current Secondary Outcome: Safety profile of eleclazine as measured by incidence of adverse events and 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: May 8, 2015
Date Started: May 2015
Date Completion:
Last Updated: December 18, 2015
Last Verified: December 2015