NCT02791815

Potential Pharmacokinetic Interaction Between Selexipag and Midazolam in Healthy Male Subjects

A Single-center, Open-label, Randomized, Two-treatment Crossover Study to Investigate the Effect of Selexipag on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Actelion · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much midazolam is present in the blood)

Detailed description

In order to exclude an inductive effect of selexipag in the gastrointestinal tract, this study aims at investigating the effect of selexipag on the PK of midazolam, a sensitive substrate of both hepatic and intestinal cytochrome P450 3A4 (CYP3A4).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Midazolam	Single oral dose of 7.5 mg midazolam (tablet)
DRUG	Selexipag	Oral administration of selexipag (200 µg film-coated tablet) for 12 consecutive days (with a titration scheme from 400 to 1600 μg b.i.d. )

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2016-06-07
• Last updated: 2016-10-13

Locations

1 site across 1 country: France