Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets

NCT06502561 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: AM-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Cmax of Aramchol

  Observed maximal concentration after administration

  10 weeks

• AUClast of Aramchol

  Area under the concentration/time curve, calculated by the trapezoidal rule from time 0 h to last observed concentration at time t

  10 weeks

• AUCinf of Aramchol

  Area under the concentration/time curve, from time 0 h extrapolated to infinity

  10 weeks

Secondary Outcomes (6)

• Tmax of Aramchol

  10 weeks

• λz of Aramchol

  10 weeks

• t½ of Aramchol

  10 weeks

• CL/F of Aramchol

  10 weeks

• VZ/F of Aramchol

  10 weeks

Study Arms (3)

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.

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)

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)

Drug: Aramchol meglumine; Drug: Aramchol free acid

Interventions

Aramchol meglumine DRUG

Aramchol meglumine is a salt form of Aramchol free acid

Also known as: Cholan-24-oic acid 7,12-dihydroxy3-[(1-oxoeicosyl)amino]-(3β,5β,7α,12α) salt with N-methyl-(D)-glucamine-Aramchol Meglumine

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 acid DRUG

Aramchol free acid is a fatty acid-bile acid conjugate

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

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• (i) 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
• 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

You may not qualify if:

• 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
• Positive drug screen
• Positive alcohol test
• Pregnant and/or nursing women. Positive pregnancy 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

Sponsors & Collaborators

• Galmed Pharmaceuticals Ltd: lead

Study Sites (1)

Diagnostic & Consultative Centre 'Ascendent' Ltd.

Sofia, 1202, Bulgaria

Location

MeSH Terms

Interventions

Salts

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Vladimir Gliut, MD

  Project management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: February 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: December 1, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)