Hepatic Impairment Clinical Trial
Official title:
A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aramchol in Subjects With Hepatic Impairment
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
Each of the 2 parts of the study will consist of a screening period, a check in day, a treatment period, and an end of study (EOS) visit. In Part 1 (single-dose): up to 48 subjects are planned: 8 subjects each in the mild (Cohort A), moderate (Cohort B), and severe (Cohort C) hepatic impairment cohorts and 8 to 24 healthy control subjects with normal hepatic function (Cohort D). Enrollment of 8 subjects with mild hepatic impairment (Cohort A) will proceed only if there is evidence of reduced clearance of aramchol in Cohort B. Assignment to cohorts A to C, will be according to Child Pugh classification system. Serial blood samples for PK analysis of aramchol concentrations in plasma will be collected before dosing (0 hour) and up to 168 hours for healthy subjects and 240 hours for hepatically impaired subjects after administration of aramchol. In Part 2 (multiple-dose), a cohort of at least 8 subjects comprising of mild, moderate or severe hepatic impaired subjects, as well as a cohort of up to 8 healthy volunteers will be administered aramchol as multiple doses to obtain the PK profile of aramchol at steady state. Aramchol will be given twice daily for 12 days. Trough blood samples for analysis of aramchol plasma concentrations will be collected before the AM dose on several days and at intervals to 12 hours after the AM dose on Day 12. ;
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