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

September 9, 2026 updated by: Galmed Pharmaceuticals Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 given one daily with that from a 300 mg dose of Aramchol free acid tablets given twice daily in adult Healthy volunteers.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A- Administration of Aramchol Meglumine tablet
12 subjects will be randomized to Part A. Participants will receive Aramchol meglumine tablet (test formulation) at 2 different single doses and plasma concentration will be assessed.
Drug: Aramchol
Aramchol tablet at 2 different single doses
Other Names:
  • 3β-arachidylamino-7α,12α-dihydroxy-5β-cholan-24-oic acid
Experimental: Part B- Administration of Aramchol meglumine or Aramchol acid tablets
20 subjects will be randomized to Part B. Participants will receive Aramchol meglumine once daily for 10 days based on a dose predicted in Part A. Steady-state plasma concentration of Aramchol will be assessed.
Drug: Aramchol
Aramchol tablet at 2 different single doses
Other Names:
  • 3β-arachidylamino-7α,12α-dihydroxy-5β-cholan-24-oic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed peak concentration (Cmax) of Aramchol
Time Frame: 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.
2 months
Time to reach maximum concentration (Tmax) of Aramchol
Time Frame: 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
2 months
Area under the plasma curve (AUC) of Aramchol
Time Frame: 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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimum observed concentration (Cmin) of Aramchol
Time Frame: 2 months
Blood samples will be collected for pharmacokinetics characterization. Cmin will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
2 months
Terminal elimination half life (T1/2) of Aramchol
Time Frame: 2 months
Blood samples will be collected for pharmacokinetics characterization. T1/2 will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
2 months
Average observed concentration (Cavg) of Aramchol
Time Frame: 2 months
Blood samples will be collected for pharmacokinetics characterization. Cavg will be calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
2 months
Safety and tolerability of Aramchol
Time Frame: 2 months
The number of participants with treatment-related adverse events, as assessed by CTCAE v4.0
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galmed Pharmaceuticals Ltd

Investigators

  • Principal Investigator: Christina Yeung, MBBS, Hammersmith Medicines Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2025

Primary Completion (Actual)

April 15, 2026

Study Completion (Estimated)

October 10, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AM-003
  • 1013148 (Registry Identifier: IRAS)
  • IRAS number- 1013148 (Other Identifier: Galmed Pharma)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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