NCT03760848

Study of Potential for Drug Interactions Mediated by CYP3A4 Inhibition With Aramchol in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Galmed Pharmaceuticals Ltd · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The trial is an open-label, 2-period, single-sequence assessment of CYP3A4 inhibition by aramchol using the probe substrates midazolam and atorvastatin to assess CYP3A4 activity.

Detailed description

Enrolment of 16 subjects is planned. Each subject will take part in 2 study periods. In Period 1, subjects will receive a single oral dose of 2 mg midazolam on Day 1 and a single oral dose of 40 mg atorvastatin on Day 3. In Period 2, subjects will receive twice-daily oral doses of 300 mg aramchol (the IMP) for 18 days. During aramchol dosing, subjects will take a single dose of 2 mg midazolam in the morning on Day 10 and 40 mg atorvastatin in the morning on Day 12. Subjects will be screened within 21 days before their first dose of study medicine. In Period 1, they will remain resident on the ward from Day -1 to Day 10. In Period 2, subjects will be admitted on Day -1 and discharged on Day 19. Subjects will attend a follow-up visit approximately 2 weeks later, on Day 33 (±2 days). There will be an interval of at least 1 day between Periods 1 and 2.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Aramchol	Aramchol 600 mg
DRUG	Midazolam	Midazolam 2 mg
DRUG	Atorvastatin	atorvastatin 40 mg

Timeline

• Start date: 2018-11-12
• Primary completion: 2019-02-02
• Completion: 2019-02-02
• First posted: 2018-11-30
• Last updated: 2019-08-22

Locations

1 site across 1 country: United Kingdom