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

NCT07251712 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: AM-0031013148IRAS number- 1013148
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum observed peak concentration (Cmax) of Aramchol

  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

  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

  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 Outcomes (4)

• Minimum observed concentration (Cmin) of Aramchol

  2 months

• Terminal elimination half life (T1/2) of Aramchol

  2 months

• Average observed concentration (Cavg) of Aramchol

  2 months

• Safety and tolerability of Aramchol

  2 months

Study Arms (2)

Part A- Administration of Aramchol Meglumine tablet

EXPERIMENTAL

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

Part B- Administration of Aramchol meglumine or Aramchol acid tablets

EXPERIMENTAL

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

Interventions

Aramchol DRUG

Aramchol tablet at 2 different single doses

Also known as: 3β-arachidylamino-7α,12α-dihydroxy-5β-cholan-24-oic acid

Part A- Administration of Aramchol Meglumine tablet; Part B- Administration of Aramchol meglumine or Aramchol acid tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galmed Pharmaceuticals Ltd: lead

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, NW10 7EW, United Kingdom

RECRUITING

MeSH Terms

Interventions

aramchol

Study Officials

• Christina Yeung, MBBS

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yossi Gilgun-Sherki, PhD, MBA

CONTACT

0543314054; yossigs@galmedpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This will be an open-label study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each participant will attend 2 trial sessions in a crossover design with a wash-out interval of at least 14 days between dosing in each session.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 26, 2025
• Study Start: December 25, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

GB (1)