A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT04250506
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Daridorexant — DRUG
    Daridorexant (ACT-541468) administered as film-coated tablets for oral use.
  • Placebo — DRUG
    Placebo administered as tablets for oral use.
  • Moxifloxacin — DRUG
    Moxifloxacin administered as film-coated tablets for oral use.

Study Details

A study to assess the effect of single doses of daridorexant on electrocardiogram parameters in healthy subjects

Key Dates

Start date
Feb 28, 2020
Status verified
Sep 2020
Primary completion
Jul 22, 2020
Completion
Jul 22, 2020

Study Design

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

Arms

  • Experimental: Treatment A: Daridorexant 50 mg
    Daridorexant (ACT-541468) administered as film-coated tablets for oral use.
  • Experimental: Treatment B: Daridorexant 200 mg
    Daridorexant (ACT-541468) administered as film-coated tablets (4 x 50 mg) for oral use.
  • Placebo Comparator: Treatment C: Placebo
    Placebo administered as tablets (4 x 50 mg) for oral use.
  • Active Comparator: Treatment D: Moxifloxacin 400 mg
    Moxifloxacin administered as film-coated tablets for oral use.

Primary Outcome Measure

Placebo-corrected change from baseline in the HR-corrected QTcF (ΔΔQTcF) [ Time Frame: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks. ]

Related Studies