NCT05480488

A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Midazolam and Warfarin in Healthy Male Subjects

A Single-center, Open-label Study to Investigate the Effect of Single- and Multiple-dose Daridorexant on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam, and the Effect of Single-dose Daridorexant on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Male Subjects

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

Summary

A study to examine the effect of daridorexant on the way the body absorbs, distributes, and gets rid of midazolam and warfarin in healthy male subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Midazolam	Subjects will receive a single oral dose of 2 mg midazolam (Treatment A, B, and C).
DRUG	Warfarin	Subjects will receive a single oral dose of 25 mg warfarin (Treatment A and B).
DRUG	Daridorexant	Subjects will receive an o.d. oral dose of 50 mg daridorexant from Day 1 to Day 7 of Treatment B and a single oral dose of 50 mg daridorexant on Day 1 of Treatment C.

Timeline

• Start date: 2022-08-23
• Primary completion: 2022-09-23
• Completion: 2022-10-06
• First posted: 2022-07-29
• Last updated: 2022-11-08

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study