Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From an Aramchol Meglumine Tablet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-25

Study Completion Date

2026-05-15

Brief Summary

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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.

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This will be an open-label study

Study Groups

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Part A- Administration of Aramchol Meglumine tablet

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.

Group Type EXPERIMENTAL

Aramchol

Intervention Type DRUG

Aramchol tablet at 2 different single doses

Part B- Administration of Aramchol meglumine or Aramchol acid tablets

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.

Group Type EXPERIMENTAL

Aramchol

Intervention Type DRUG

Aramchol tablet at 2 different single doses

Interventions

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Aramchol

Aramchol tablet at 2 different single doses

Intervention Type DRUG

Other Intervention Names

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3β-arachidylamino-7α,12α-dihydroxy-5β-cholan-24-oic acid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes