RecruitingPhase 1NCT07251712

Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From an Aramchol Meglumine Tablet

A Phase I Open-label Trial in Healthy Volunteers to Evaluate the Exposure of Aramchol From Two Different Single Doses of an Aramchol Meglumine Tablet

Sponsor

Galmed Pharmaceuticals Ltd

Enrollment

32 participants

Start Date

Dec 25, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy

Summary

Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine tablet.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

Male or female healthy volunteers with body mass index (BMI) in the range of 18-30.9 kg/ m2 inclusive
Deemed healthy on the basis of clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
Agree to follow-up the contraception requirements of the trial
Able to give fully informed written consent

Exclusion Criteria9

Females of reproductive potential who are pregnant or lactating
Positive tests for hepatitis B, C or HIV
History of sever adverse reaction to any drug
Known sensitivity to drug medication
Drug or alcohol abuse
Smoking in the 3 months prior the study
Clinically relevant abnormal lab results, medical history or concurrent medical condition
Evidence of acute or chronic disease
Inability to adhere to study requirements