Healthy Clinical Trial
Official title:
Study of Potential for Drug Interactions Mediated by CYP3A4 Inhibition With Aramchol in Healthy Volunteers
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.
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.
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