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

NCT07251712 · tracked via the Priya Life Science UK tracker

Sponsor

Galmed Pharmaceuticals Ltd

Phase

Phase 1

Started

2025-12-25

Last updated

2026-09-10

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

Aramchol

Aramchol: Aramchol tablet at 2 different single doses

Study 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

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

Accepted

Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Maximum observed peak concentration (Cmax) of Aramchol — 2 months
Blood samples will be collected for pharmacokinetics characterization. Cmax will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Time to reach maximum concentration (Tmax) of Aramchol — 2 months
Blood samples will be collected for pharmacokinetics characterization. Tmax will be calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics
Area under the plasma curve (AUC) of Aramchol — 2 months
Blood samples will be collected for pharmacokinetics characterization. AUC of Aramchol will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.

Trial sites (1)

Facility	City	Region	Status
Hammersmith Medicines Research (HMR)	London	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07251712 on ClinicalTrials.gov ↗ ← All trials in the UK