NCT07251712

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

A Phase I Open-label Trial in Healthy Volunteers to Evaluate the Exposure of Aramchol From Two Different Single Doses of an Aramchol Meglumine Tablet

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Galmed Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Aramchol	Aramchol tablet at 2 different single doses

Timeline

• Start date: 2025-12-25
• Primary completion: 2026-04-15
• Completion: 2026-05-15
• First posted: 2025-11-26
• Last updated: 2026-03-17

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study