HealthyPhase 1NCT07251712
Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From an Aramchol Meglumine Tablet
A Phase 1 study testing Aramchol in people with Healthy, run by Galmed Pharmaceuticals Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aramchol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Dec 2025to 10 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Clinically relevant abnormal lab results, medical history or concurrent medical condition
- Evidence of acute or chronic disease
- Inability to adhere to study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Hammersmith Medicines Research (HMR)
London, NW10 7EW
Adeep Puri, M.D., apuri@hmrlondon.com
About this study
Official 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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Aramchol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AramcholDrug
Also called 3β-arachidylamino-7α,12α-dihydroxy-5β-cholan-24-oic acid
Aramchol tablet at 2 different single doses
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Aramchol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 2 months
Secondary outcomes (4)
Minimum observed concentration (Cmin) of Aramchol
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.
Measured: 2 months
Terminal elimination half life (T1/2) of Aramchol
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.
Measured: 2 months
Average observed concentration (Cavg) of Aramchol
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.
Measured: 2 months
Safety and tolerability of Aramchol
The number of participants with treatment-related adverse events, as assessed by CTCAE v4.0
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start25 Dec 2025
- Primary completion15 Apr 2026
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galmed Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christina Yeung, MBBS, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251712
- Sponsor's protocol ID
- AM-003
- Other IDs
- 1013148, IRAS number- 1013148
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07251712
- Acronym / sponsor ID
- AM-003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Galmed Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part A- Administration of Aramchol Meglumine tablet | Experimental | Drug: Aramchol12 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. |
| Part B- Administration of Aramchol meglumine or Aramchol acid tablets | Experimental | Drug: Aramchol20 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AramcholAlso: 3β-arachidylamino-7α,12α-dihydroxy-5β-cholan-24-oic acidAramchol tablet at 2 different single doses | Drug | Part A- Administration of Aramchol Meglumine tablet, Part B- Administration of Aramchol meglumine or Aramchol acid tablets |
Primary outcome
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.
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
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.
4 secondary outcomes
Minimum observed concentration (Cmin) of Aramchol
Time frame: 2 months
Terminal elimination half life (T1/2) of Aramchol
Time frame: 2 months
Average observed concentration (Cavg) of Aramchol
Time frame: 2 months
Safety and tolerability of Aramchol
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Yeung, MBBS principal investigator
Hammersmith Medicines Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aramchol in people with Healthy, run by Galmed Pharmaceuticals Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yossi Gilgun-Sherki, PhD, MBA (0543314054, yossigs@galmedpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed peak concentration (Cmax) of Aramchol (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.