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

Galmed Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Aramchol

Study type: Interventional

Funder types: Industry

Identifiers

NCT07251712

IRAS number- 1013148 (Other Identifier)

AM-003

1013148 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Part A- Administration of Aramchol Meglumine tablet

Experimental group

Description:

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.

Treatment:

Drug: Aramchol

Part B- Administration of Aramchol meglumine or Aramchol acid tablets

Experimental group

Description:

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.

Treatment:

Drug: Aramchol