At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 49 enrolled
Drug / intervention
Eleclazinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Eleclazine for Long QT Syndrome. Completed, enrolled 49 participants across 7 sites in 4 countries.
Detailed Summary
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral eleclazine and its metabolite, GS-623134, 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%).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLong QT Syndrome
CountriesGermany, New Zealand, Romania, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedApr 2015
Primary CompletionApr 2016
TodayJul 2026
First PostedApr 8, 2015
Enrollment StartMar 19, 2015
Primary CompletionApr 22, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.2 years ago
Interventions
Eleclazinedrug
Eleclazine tablets administered orally