A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants

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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03682380
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Seltorexant High Dose — DRUG
    In Part 1, Part 2, and Part 3 (3A and 3C), Seltorexant high dose (either a high dose tablet or two low dose tablets) will be administered orally.
  • Seltorexant Low Dose — DRUG
    In Part 3 (3B and 3C), Seltorexant low dose will be administered orally.

Study Details

The purpose of this study is to compare the rate and extent of absorption (relative bioavailability) of seltorexant Phase 3 test formulation(s) relative to a reference Phase 2b tablet formulation dosed in the evening under fasted and semi-fasted conditions (3 hours after meal); to assess the effect of type and timing of the meal on the rate and extent of absorption of seltorexant Phase 3 tablet formulation (low dose and high dose strength) in healthy male and female participants; and to assess the pharmacokinetic of single-dose administration of low dose and high dose of seltorexant in healthy male and female participants 3 hours after meal.

Key Dates

Start date
Oct 1, 2018
Status verified
Apr 2025
Primary completion
Aug 23, 2019
Completion
Aug 23, 2019

Study Design

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

Arms

  • Experimental: Part 1: Seltorexant High Dose
    In Part 1, participants will receive the following treatments: Treatment A: Two low doses of seltorexant tablets (reference formulation), Treatment B: High dose of seltorexant tablet (Test formulation 1), Treatment C: High dose of seltorexant tablet (Test formulation 2), Treatment D: Two low doses of seltorexant tablets (Test formulation 3), Treatment E: Two low doses of seltorexant tablets (Test formulation 4), Treatment F: Two low doses of seltorexant tablets (Test formulation 5), as one of 6 possible treatment sequences on Day 1 in each treatment Periods (Period 1-6). There will be a washout Period of 7 to 14 days from dosing on Day 1 of each treatment period.
  • Experimental: Part 2: Seltorexant High Dose
    Participants will receive the following treatments: Treatment G: Two low doses of seltorexant tablets (Reference formulation), Treatment H: High dose or two low doses of seltorexant tablet (Test formulation 1), Treatment I: High dose of seltorexant tablet (Test formulation 2), as one of 6 possible treatment sequences on Day 1 in each treatment Periods (Period 1-3). There will be a washout period of 7 to 14 days from dosing on Day 1 of each treatment period.
  • Experimental: Part 3: Seltorexant Low Dose or High Dose
    Part 3 will have 3 subparts (Part 3A, Part 3B, and Part 3C). In Part 3A and 3B, participants will receive high dose of seltorexant (selected formulation 6) and two low doses of seltorexant (selected formulation 7) respectively in a different food conditions on Day 1 in each treatment Periods (Periods 1-5). In Part 3C, participants will receive high dose of seltorexant (selected formulation 6) and two low doses of seltorexant (selected formulation 7 ) on Day 1 in each period (Period 1 and 2). 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) [ Time Frame: Predose up to 48 hours postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
PRAHSSalt Lake CityUtah84124-

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By research site
PRAHS· Salt Lake City, UT

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