A Study of Seltorexant in Healthy Participants

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04553042
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Seltorexant — DRUG
    Seltorexant will be administered orally as per assigned treatment sequence.

Study Details

The purpose of this study is to evaluate the bioequivalence of Test 1 and/or Test 2 seltorexant tablet formulations with respect to Reference seltorexant tablet formulation in healthy participants receiving a single dose under fasted conditions.

Key Dates

Start date
Sep 14, 2020
Status verified
Apr 2025
Primary completion
Dec 20, 2020
Completion
Dec 30, 2020

Study Design

Enrollment
69 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment Sequence ABC
    Participants will receive a single dose of seltorexant as formulation (Test 1) (Treatment A) in Treatment Period 1, followed by a single dose of seltorexant as formulation (Test 2) (Treatment B) in Treatment Period 2, followed by a single dose of seltorexant as formulation (Reference) (Treatment C) in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.
  • Experimental: Treatment Sequence BCA
    Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.
  • Experimental: Treatment Sequence CAB
    Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.
  • Experimental: Treatment Sequence CBA
    Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.
  • Experimental: Treatment Sequence ACB
    Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.
  • Experimental: Treatment Sequence BAC
    Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Seltorexant and its Metabolites [ Time Frame: Predose, up to 48 hours post dose (Day 3) ]

Locations (1)

FacilityCityStateZIPSite coordinators
PRA Health SciencesSalt Lake CityUtah84124-

Find similar trials in Salt Lake City, UT

By research site
PRA Health Sciences· Salt Lake City, UT

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