NCT04480827

Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment

A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aramchol in Subjects With Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Galmed Research and Development, Ltd. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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

Detailed description

Each of the 2 parts of the study consisted of a screening period, a check in day, a treatment period, and an end of study (EOS) visit. In Part 1 (single-dose): 39 subjects were enrolled: 8 subjects each in the mild (Cohort A), moderate (Cohort B), and severe (Cohort C) hepatic impairment cohorts and 15 healthy control subjects with normal hepatic function (Cohort D). Enrollment of 8 subjects with mild hepatic impairment (Cohort A) proceeded only if there is evidence of reduced clearance of aramchol in Cohort B. Assignment to cohorts A to C, was according to Child Pugh classification system. Serial blood samples for PK analysis of aramchol concentrations in plasma were 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 4 subjects comprising of mild, 7 moderate , as well as a cohort of 7 healthy volunteers was administered with aramchol as multiple doses to obtain the PK profile of aramchol at steady state. Aramchol was given twice daily for 12 days. Trough blood samples for analysis of aramchol plasma concentrations was collected before the AM dose on several days and at intervals to 12 hours after the AM dose on Day 12.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Aramchol free acid tablet 600mg, single dose	Aramchol free acid tablet 600mg, single dose
DRUG	Aramchol free acid tablet 300mg, bid	Aramchol acid tablet 300mg, bid for 12 days

Timeline

• Start date: 2020-02-13
• Primary completion: 2022-03-24
• Completion: 2022-03-24
• First posted: 2020-07-21
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study