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NCT Number: NCT07251712

Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research (HMR)

London, NW10 7EW, United Kingdom

Location status: Recruiting

Location contact

Adeep Puri, M.D.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aramchol

Drug

Aramchol tablet at 2 different single doses

Other names: 3β-arachidylamino-7α,12α-dihydroxy-5β-cholan-24-oic acid

Primary outcomes

  1. 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. 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

  3. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. Safety and tolerability of Aramchol

    Time frame: 2 months

    The number of participants with treatment-related adverse events, as assessed by CTCAE v4.0

Study contacts

Contact information is provided by the study sponsor or research team.

Yossi Gilgun-Sherki, PhD, MBA

CONTACT

[email protected]

0543314054

Sponsors and collaborators

Lead sponsor

Galmed Pharmaceuticals Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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