NCT06502561

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Galmed Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

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 and 1 single dose of Aramchol free acid under fasting conditions. A single 400 mg dose of Aramchol meglumine (Test 1) will be administered to all study subjects in Period 1. The second dose of Aramchol meglumine 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 (Test 2) in one period and a 300 mg tablet of Aramchol free acid (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

Interventions

Type	Name	Description
DRUG	Aramchol meglumine	Aramchol meglumine is a salt form of Aramchol free acid
DRUG	Aramchol free acid	Aramchol free acid is a fatty acid-bile acid conjugate

Timeline

• Start date: 2025-02-15
• Primary completion: 2025-06-15
• Completion: 2025-12-01
• First posted: 2024-07-16
• Last updated: 2025-11-17

Locations

1 site across 1 country: Bulgaria

Regulatory

• FDA-regulated drug study