NCT03774173

Comparison of Aramchol Concentrations With Once or Twice Daily Dosing

A Randomised, Open-label Study to Compare Plasma Concentrations of Aramchol in Healthy Volunteers After Once or Twice Daily Oral Dosing to Steady State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Galmed Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The trial is an open-label, 2-period, randomised, crossover study of the plasma concentrations of aramchol, in which subjects will receive oral doses of aramchol at 300 mg twice daily and 600 mg once daily.

Detailed description

The trial is an open-label, 2-period, randomised, crossover study of the plasma concentrations of aramchol, in which subjects will receive oral doses of aramchol at 300 mg twice daily (every 12 h) for 9 days in one period, with a single dose in the morning of Day 10, and 600 mg once daily (every 24 h) for 10 days in the other period. A pharmacokinetic profile will be obtained over the dosing interval on Day 10 of each period. Enrolment of 16 subjects is planned with each subject taking part in the 2 study periods. The subjects will be randomised 1:1 so that 8 subjects receive each regimen in the first period and the alternate regimen in the second period. Subjects will be screened within 21 days before their first dose of study medicine. In each period they will remain resident on the ward from Day -1 until the morning of Day 11. Subjects will attend a follow-up visit 14 days (±2 days) after the end of the second period. There will be an interval of at least 7 days between Periods 1 and 2.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Aramchol	One Aramchol tablet (300 mg) twice daily and 2 Aramchol tablets (300 mg each) once daily

Timeline

• Start date: 2018-12-08
• Primary completion: 2019-02-03
• Completion: 2019-03-05
• First posted: 2018-12-12
• Last updated: 2019-08-09

Locations

1 site across 1 country: United Kingdom