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.

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT04390334
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 13, 2020
Status verified
Sep 2020
Primary completion
Jun 26, 2020
Completion
Jun 26, 2020

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Treatment A: Daridorexant
    Single dose of 50 mg daridorexant
  • Experimental: Treatment B: Famotidine & daridorexant
    Single dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant
  • Experimental: Treatment C: Efavirenz
    600 mg efavirenz once daily in the evening from Day 5 to Day 14
  • Experimental: Treatment D: Daridorexant & efavirenz
    Single dose of 50 mg daridorexant in the morning of Day 15 followed by a single dose of 600 mg efavirenz in the evening of Days 15 and 16

Primary Outcome Measure

PK parameter of daridorexant: Maximum plasma concentration (Cmax) [ Time Frame: Various time points during Treatment A through D (Total duration: up to 3 weeks). ]

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