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

NCT04480827 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-08-14

Study results available
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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

Conditions

  • Hepatic Impairment

Interventions

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

Sponsors & Collaborators

  • Galmed Research and Development, Ltd.

    lead INDUSTRY

Principal Investigators

  • Yossi Gilgun-Sherki, PhD, MBA · Executive Drug Development Consultant

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2022-03-24
Completion
2022-03-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04480827 on ClinicalTrials.gov