How Aramchol meglumine tablets are absorbed after single and repeated doses
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
This study will test how two single doses and a once-daily repeated dose of Aramchol meglumine tablets are absorbed and processed in healthy adults compared with a twice-daily 300 mg Aramchol free acid tablet.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Galmed Pharmaceuticals Ltd Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT07251712 on ClinicalTrials.gov |
What this trial studies
This Phase 1 pharmacokinetic study enrolls healthy adult volunteers to receive two different single doses of Aramchol meglumine and a selected dose given once daily to steady state, with comparison to a 300 mg Aramchol free acid tablet given twice daily. Blood samples will be collected over time to measure drug exposure (PK) and participants will be monitored with labs, ECGs, and vital signs for safety. The study is conducted at a single early-phase clinical site with standardized dosing and sampling procedures. Results will inform dosing choices and formulation development for later patient studies.
Who should consider this trial
Good fit: Healthy men and women aged as specified who have a BMI of 18.0–30.9 kg/m2, normal screening labs and exams, agree to contraception rules, and can provide informed consent.
Not a fit: People with active or chronic medical conditions, pregnant or breastfeeding individuals, recent smokers, or those with positive hepatitis or HIV tests will be excluded and are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this could identify a once-daily Aramchol meglumine dose with similar or improved exposure compared with the twice-daily free acid tablet, simplifying dosing and guiding future patient trials.
How similar studies have performed: Pharmacokinetic studies of Aramchol and other formulations have been performed before, but direct comparison of a meglumine tablet to the free acid twice-daily formulation is a relatively specific formulation/PK question.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Hammersmith Medicines Research (HMR) — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Christina Yeung, MBBS — Hammersmith Medicines Research
- Study coordinator: Yossi Gilgun-Sherki, PhD, MBA
- Email: yossigs@galmedpharma.com
- Phone: 0543314054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.