NCT04390334

A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant.

Single-center, Randomized, Open-label Study to Investigate the Effect of Single-dose Famotidine and Multiple-dose Efavirenz on the Pharmacokinetics of Daridorexant in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A study in healthy male subjects to investigate the effect of famotidine and efavirenz on the way the body takes up, distributes, and gets rid of daridorexant.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Daridorexant	Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.
DRUG	Famotidine	Famotidine will be administered orally as 1 film-coated tablet of 40 mg strength to be taken in the morning under fasted conditions.
DRUG	Efavirenz	Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.

Timeline

• Start date: 2020-05-13
• Primary completion: 2020-06-26
• Completion: 2020-06-26
• First posted: 2020-05-15
• Last updated: 2020-09-16

Locations

1 site across 1 country: Germany