A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants

Part of paid clinical trials in Anaheim, California.

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT05877222
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Daridorexant 10 mg — DRUG
    Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 10 mg.
  • Daridorexant 25 mg — DRUG
    Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 25 mg.

Study Details

A Phase 1 trial to investigate bioequivalence between 5 × 10 mg tablets and 2 × 25 mg tablets of daridorexant in healthy male and female Japanese participants

Key Dates

Start date
Jun 23, 2023
Status verified
Aug 2023
Primary completion
Aug 4, 2023
Completion
Aug 4, 2023

Study Design

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

Arms

  • Experimental: Treatment A (5 × 10 mg daridorexant)
    Participants will receive a single oral dose of 5 × 10 mg daridorexant.
  • Experimental: Treatment B (5 × 25 mg daridorexant)
    Participants will receive a single oral dose of 2 × 25 mg daridorexant.

Primary Outcome Measure

Cmax [ Time Frame: Blood samples for PK analysis will be taken at several timepoints from treatment administration on Day 1 to Day 3 of Study periods 1 and 2 (Total duration: up to 4 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Anaheim Clinical TrialsAnaheimCalifornia92801-

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Anaheim Clinical Trials· Anaheim, CA

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