HealthyPhase 1NCT06502561
Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets
A Phase 1 study testing Aramchol meglumine and Aramchol free acid in people with Healthy, run by Galmed Pharmaceuticals Ltd at 1 site in Bulgaria.
Trial summary
This is a Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine (AM) Granules For Oral Suspension To Aramchol Free Acid (AA) 300 mg Tablets In Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aramchol meglumine and Aramchol free acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBulgaria
- Study dates
- 15 Feb 2025to 17 Nov 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects
- Age between 18 and 45 years (inclusive of the date of signing the informed consent form)
- Male subjects must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and up to the study completion visit
- Female subjects who are not of reproductive potential. A female subject who is not of reproductive potential is defined as a subject who:
- has reached natural menopause (defined as at least 12 months of spontaneous amenorrhea); (ii) is at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (iii) has undergone bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying cause (e.g., anorexia nervosa).
- Female subjects who are of reproductive potential and use reliable contraception method and/or are willing to use adequate birth control methods starting from at least 4 weeks prior to the screening visit and for the duration of the study through 30 days after the last dose of study drug
Show all 14Show fewer
- List of medically accepted contraceptive methods:
- Combination of a barrier method and spermicides (film, jelly, foam): female/ male condoms with spermicides, as well as a diaphragm/ cervical cap/ contraceptive sponge with spermicides.
- Hormonal methods: combined estrogen/progestin injectable and oral contraceptives; progestin injectable and oral contraceptives; implants (Nexplanon®), vaginal ring (NuvaRing®), skin patch (Xulane®) and contraceptive injection (Depo-Provera®).
- Intrauterine devices (IUD): inert or copper IUD (ParaGard®), hormonal IUD (Mirena®, Skyla®, Kyleena®).
- Physically and mentally healthy as judged by means of medical and standard laboratory examinations
- Non-smokers or ex-smokers (stopped at least 12 months ago) and non-users of other nicotine containing products, confirmed by urine cotinine test
- Body mass index (BMI) within the range (including the borders) of 18.0 to 29.9 kg/m2
- Informed consent given in written form according to Section 5.3 of clinical study protocol
Who cannot join
- Participation in another clinical study at the same time or within 90 days before the screening visit (calculated from the date of the final examination of the previous study)
- Randomization into the present study more than once
- Blood donation or blood loss including plasmapheresis of >500 mL within 90 days before screening visit
- History of drug abuse or use of illegal drugs: use of soft drugs, marihuana within 6 months before screening visit or hard drugs, cocaine, amphetamines, phencyclidine within 1 year before screening visit
- Alcohol abuse, regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits) or recovered alcoholics
- Regular consumption of beverages or food containing methylxanthines (coffee, tea, cola, caffeine containing sodas, chocolate) equivalent to more than 500 mg methylxanthines per day
Show all 36Show fewer
- Positive drug screen
- Positive alcohol test
- Pregnant and/or nursing women. Positive pregnancy Human chorionic gonadotropin (hCG) test
- Allergic diathesis or any clinically significant allergic disease (asthma or bronchial hyperreactivity)
- Any history of drug hypersensitivity especially to the active and inactive ingredients of the Aramchol meglumine or Aramchol free acid preparations, including cholic acid
- Presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
- Clinically significant illness within 4 weeks before screening visit
- Major surgery of the gastrointestinal tract except for appendectomy
- Any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug
- History of difficulty in swallowing
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
- Administration of depot injectable solutions or medications with a half-life > 1 week (including study medications) within 3 months before screening visit
- Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before screening visit
- Intake or administration of any oral, systemic or topical medication [including Over The Counter (OTC) medication] other than paracetamol and especially intake of antacids: aluminum hydroxide, magnesium hydroxide, and simethicone or herbal medication: St. John's wort, kava kava) within 2 weeks before screening visit
- Vaccination within 14 days prior to screening visit
- Medication with drugs known to alter the major organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within 60 days before screening visit
- Systolic blood pressure outside the range of 100 to 140 mmHg and/or diastolic blood pressure outside the range of 60 to 90 mmHg
- Pulse rate outside the range of 45 to 100 beats/min
- Axillary body temperature outside the interval of 35.5 to 37.0°C
- Any clinically significant abnormality of the resting 12-lead Electrocardiogram (ECG)
- Laboratory values outside the normal range with clinical relevance
- Special diet due to any reason (vegetarian)
- Body weight loss of more than 10 kg in the last two months
- History or presence of piercings in the mouth (tongue, lips) or wearing braces or dentures
- Subjects who are known or suspected:
- not to comply with the study directives
- not to be reliable or trustworthy
- not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
- to be in such a precarious financial situation that they no longer are able to weigh up the possible risks of their participation and the unpleasantness they may be involved in
- subject is in custody or submitted to an institution due to a judicial order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine Granules For Oral Suspension To Aramchol Free Acid 300 mg Tablets In Healthy Volunteers
This is a Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine (AM) Granules For Oral Suspension To Aramchol Free Acid (AA) 300 mg Tablets In Healthy Volunteers
Read the detailed description
A single center, 3-period, open-label, crossover study in healthy male and female volunteers who will receive 2 single doses of Aramchol meglumine (AM) and 1 single dose of Aramchol free acid (AA) under fasting conditions.
A single 400 mg dose of Aramchol meglumine (AM; Test 1) will be administered to all study subjects in Period 1.
The second dose of Aramchol meglumine (AM) will be between 200 mg and 800 mg and will be selected after review of the pharmacokinetics (PK) from Period 1.
In Periods 2 and 3, study subjects will be randomized 1:1 to receive the second dose of Aramchol meglumine (AM; Test 2) in one period and a 300 mg tablet of Aramchol free acid (AA; Reference) in the other period. Each product will be given under fasting conditions. The study periods will be separated by a wash-out period of at least 14 days.
- Conditions
- Healthy
- Being tested
- Aramchol meglumine, Aramchol free acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aramchol meglumineDrug
Also called Cholan-24-oic acid 7,12-dihydroxy3-[(1-oxoeicosyl)amino]-(3β,5β,7α,12α) salt with N-methyl-(D)-glucamine-Aramchol Meglumine
Aramchol meglumine is a salt form of Aramchol free acid
Aramchol free acidDrug
Also called 3β-arachidylamido-7α,12α-dihydroxy-5β-cholan-24-oic acid
Aramchol free acid is a fatty acid-bile acid conjugate
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving a single 400 mg dose of Aramchol meglumine in Period 1 | Experimental | A single 400 mg dose of Aramchol meglumine will be administered to all study subjects in Period 1. Receives: Drug: Aramchol meglumine |
| Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 2 | Active comparator | In Period 2, study subjects will be randomized 1:1 to receive Aramchol meglumine or 300 mg tablet of Aramchol free acid (Reference) Receives: Drug: Aramchol meglumine; Drug: Aramchol free acid |
| Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 3 | Active comparator | In Period 3, study subjects will be randomized 1:1 to receive Aramchol meglumine or 300 mg tablet of Aramchol free acid (Reference) Receives: Drug: Aramchol meglumine; Drug: Aramchol free acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Aramchol
Observed maximal concentration after administration
Measured: 8 days 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
AUClast of Aramchol
Area under the concentration/time curve to the last measurable concentration, calculated by the trapezoidal rule from time 0 h to last observed concentration at time t
Measured: 8 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
AUCinf of Aramchol
Area under the concentration/time curve, from time 0 h extrapolated to infinity
Measured: 8 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
Secondary outcomes (6)
Tmax of Aramchol
Observed time point of maximal concentration
Measured: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
λz of Aramchol
Terminal rate constant in both study periods
Measured: 8 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
t½ of Aramchol
Plasma concentration half-life
Measured: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
CL/F of Aramchol
Clearance per fraction of bioavailability
Measured: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
VZ/F of Aramchol
Volume of distribution per fraction of bioavailability
Measured: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
%AUCextrap of Aramchol
The percentage of the area under the concentration-time curve (%AUC) that is extrapolated beyond the last observed data point
Measured: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start15 Feb 2025
- Primary completion15 Jun 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- All subjects will receive a single dose of 400 mg Aramchol meglumine granules for oral suspension (Test 1) in Period 1. In Periods 2 and 3, subjects will be randomized to a crossover of treatments in a 1:1 ratio to receive a single dose of Aramchol meglumine granules for oral suspension (Test 2) in one period and a 300 mg Aramchol free acid tablet (Reference) in the other period. The washout interval between dosing periods will be at least 14 days.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galmed Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Gliut, MD, Principal investigator, Project management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502561
- Sponsor's protocol ID
- AM-001
- Status last verified
- Mar 2026
- First submitted
- 9 Jul 2024
- Last updated
- 1 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine Granules For Oral Suspension To Aramchol Free Acid 300 mg Tablets In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06502561
- Acronym / sponsor ID
- AM-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Galmed Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Posted 1 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine (AM) Granules For Oral Suspension To Aramchol Free Acid (AA) 300 mg Tablets In Healthy Volunteers
Detailed description
A single center, 3-period, open-label, crossover study in healthy male and female volunteers who will receive 2 single doses of Aramchol meglumine (AM) and 1 single dose of Aramchol free acid (AA) under fasting conditions.
A single 400 mg dose of Aramchol meglumine (AM; Test 1) will be administered to all study subjects in Period 1.
The second dose of Aramchol meglumine (AM) will be between 200 mg and 800 mg and will be selected after review of the pharmacokinetics (PK) from Period 1.
In Periods 2 and 3, study subjects will be randomized 1:1 to receive the second dose of Aramchol meglumine (AM; Test 2) in one period and a 300 mg tablet of Aramchol free acid (AA; Reference) in the other period. Each product will be given under fasting conditions. The study periods will be separated by a wash-out period of at least 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All subjects will receive a single dose of 400 mg Aramchol meglumine granules for oral suspension (Test 1) in Period 1. In Periods 2 and 3, subjects will be randomized to a crossover of treatments in a 1:1 ratio to receive a single dose of Aramchol meglumine granules for oral suspension (Test 2) in one period and a 300 mg Aramchol free acid tablet (Reference) in the other period. The washout interval between dosing periods will be at least 14 days.
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving a single 400 mg dose of Aramchol meglumine in Period 1 | Experimental | Drug: Aramchol meglumineA single 400 mg dose of Aramchol meglumine will be administered to all study subjects in Period 1. |
| Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 2 | Active comparator | Drug: Aramchol meglumine, Drug: Aramchol free acidIn Period 2, study subjects will be randomized 1:1 to receive Aramchol meglumine or 300 mg tablet of Aramchol free acid (Reference) |
| Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 3 | Active comparator | Drug: Aramchol meglumine, Drug: Aramchol free acidIn Period 3, study subjects will be randomized 1:1 to receive Aramchol meglumine or 300 mg tablet of Aramchol free acid (Reference) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male or female subjects
- Age between 18 and 45 years (inclusive of the date of signing the informed consent form)
- Male subjects must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and up to the study completion visit
- Female subjects who are not of reproductive potential. A female subject who is not of reproductive potential is defined as a subject who:
- Female subjects who are of reproductive potential and use reliable contraception method and/or are willing to use adequate birth control methods starting from at least 4 weeks prior to the screening visit and for the duration of the study through 30 days after the last dose of study drug
Key exclusion criteria (36 listed)
- Participation in another clinical study at the same time or within 90 days before the screening visit (calculated from the date of the final examination of the previous study)
- Randomization into the present study more than once
- Blood donation or blood loss including plasmapheresis of >500 mL within 90 days before screening visit
- History of drug abuse or use of illegal drugs: use of soft drugs, marihuana within 6 months before screening visit or hard drugs, cocaine, amphetamines, phencyclidine within 1 year before screening visit
- Alcohol abuse, regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits) or recovered alcoholics
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 |
|---|---|---|
| Aramchol meglumineAlso: Cholan-24-oic acid 7,12-dihydroxy3-[(1-oxoeicosyl)amino]-(3β,5β,7α,12α) salt with N-methyl-(D)-glucamine-Aramchol MeglumineAramchol meglumine is a salt form of Aramchol free acid | Drug | Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 2, Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 3, Subjects receiving a single 400 mg dose of Aramchol meglumine in Period 1 |
| Aramchol free acidAlso: 3β-arachidylamido-7α,12α-dihydroxy-5β-cholan-24-oic acidAramchol free acid is a fatty acid-bile acid conjugate | Drug | Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 2, Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 3 |
Primary outcome
Cmax of Aramchol
Time frame: 8 days 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
Observed maximal concentration after administration
AUClast of Aramchol
Time frame: 8 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
Area under the concentration/time curve to the last measurable concentration, calculated by the trapezoidal rule from time 0 h to last observed concentration at time t
AUCinf of Aramchol
Time frame: 8 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
Area under the concentration/time curve, from time 0 h extrapolated to infinity
6 secondary outcomes
Tmax of Aramchol
Time frame: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
λz of Aramchol
Time frame: 8 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
t½ of Aramchol
Time frame: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
CL/F of Aramchol
Time frame: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
VZ/F of Aramchol
Time frame: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
%AUCextrap of Aramchol
Time frame: 24 days. 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Vladimir Gliut, MD principal investigator
Project management
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 meglumine and Aramchol free acid in people with Healthy, run by Galmed Pharmaceuticals Ltd at 1 site in Bulgaria.
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 14 inclusion and 36 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: finished, as of the sponsor's last update on 1 Jun 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 Bulgaria. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of Aramchol (time frame: 8 days 19 blood samples were drawn in each study period: within 10 minutes pre-dose and 2, 3, 4, 6, 8, 10, 12,14, 18, 24, 30, 36, 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144(Day 7), 168 hours (Day 8) post-dose.). 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 1 Jun 2026.