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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03760848
Study type Interventional
Source Galmed Pharmaceuticals Ltd
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 12, 2018
Completion date February 2019

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