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

NCT06502561 | Completed Phase 1 Results 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 (AM) Granules For Oral Suspension To Aramchol Free Acid (AA) 300 mg Tablets In Healthy Volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Cmax of Aramchol

  Observed maximal concentration after administration

  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

  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

  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

  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

  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

  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

  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

  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.

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 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

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

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 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

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

Results Point of Contact

• Title: Yossi Gilgun-Sherki, PhD, Executive Drug Development Consultant
• Organization: Galmed Pharmaceuticals

yossigs@galmedpharma.com

972543314054

Study Officials

• Vladimir Gliut, MD

  Project management

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: 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: November 17, 2025
• Last Updated: June 1, 2026
• Results First Posted: June 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)