A Study to Evaluate the Effects of Single-dose Seltorexant on Electrocardiogram Intervals in Healthy Adult Participants

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03494907
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Seltorexant — DRUG
    Participants will be administered oral dose of seltorexant over-encapsulated tablets on Day 1.
  • Placebo Matched to Seltorexant — OTHER
    Participants will be administered matching placebo to seltorexant tablets on Day 1.
  • Placebo Matched to Moxifloxacin — OTHER
    Participants will be administered oral dose of moxifloxacin placebo tablet on Day 1.
  • Moxifloxacin Dose 1 — DRUG
    Participants will be administered oral dose 1 of moxifloxacin on Day 1.

Study Details

The purpose of this study is to assess the effects of single dose seltorexant on QT/QTc intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy adult participants.

Key Dates

Start date
Apr 9, 2018
Status verified
Apr 2025
Primary completion
Aug 13, 2018
Completion
Aug 13, 2018

Study Design

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

Arms

  • Experimental: Seltorexant (Low and high dose)
    Participants will receive seltorexant tablets orally in 2 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period.
  • Experimental: Moxifloxacin
    Participants will receive moxifloxacin tablets orally in 1 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period.
  • Experimental: Placebo Matched to Seltorexant
    Participants will receive seltorexant placebo tablets orally in 3 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period.
  • Experimental: Placebo Matched to Moxifloxacin
    Participants will receive moxifloxacin placebo tablets orally in 3 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period.

Primary Outcome Measure

Change From Baseline in QT/QTc Intervals [ Time Frame: Baseline up to Day 3 ]

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