At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 57 enrolled
Drug / intervention
Aramchol free acid tablet 600mg, single dose +1 moredrug
Likely dose
Aramchol free acid tablet 600mg, single dosefrom 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 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aramchol in Subjects With Hepatic Impairment
In Brief
A Phase 1 clinical trial evaluating Aramchol free acid tablet 600mg, single dose and Aramchol free acid tablet 300mg, bid for Hepatic Impairment. Completed, enrolled 57 participants across 3 sites.
Detailed Summary
Phase 1, multicenter, open-label, 2-part, single- and multiple-dose study designed to assess the effect of hepatic insufficiency on the PK of aramchol
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
Enrollment StartFeb 2020
First PostedJul 2020
Primary CompletionMar 2022
TodayJul 2026
First PostedJul 21, 2020
Enrollment StartFeb 13, 2020
Primary CompletionMar 24, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.9 years ago
Interventions
Aramchol free acid tablet 600mg, single dosedrug
Aramchol free acid tablet 600mg, single dose
Aramchol free acid tablet 300mg, biddrug
Aramchol acid tablet 300mg, bid for 12 days