A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Participants Under Fasted and Semi-fasted Conditions

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

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03438461
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Seltorexant 40 mg — DRUG
    Seltorexant 40 mg as two tablets of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 1.
  • Seltorexant 20 mg — DRUG
    Seltorexant as a tablet of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 2.

Study Details

The purpose of this study is to assess and compare the pharmacokinetics (PK) and relative oral bioavailability of 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions.

Key Dates

Start date
Feb 9, 2018
Status verified
Apr 2025
Primary completion
May 30, 2018
Completion
May 30, 2018

Study Design

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

Arms

  • Experimental: Part 1
    In Part 1, all participants will receive a single oral dose of seltorexant (40 milligram \[mg\]) in all the 6 treatments as Treatment A (Formulation 1 in fasted state), B (Formulation 1 in semi-fasted state), C (Formulation 2 in fasted state), D (Formulation 2 in semi-fasted state), E (Formulation 3 in fasted state) and F (Formulation 3 in semi-fasted state) and the participants will be assigned to one of the 8 sequences (that is, ADBCEF, ADBCFE, BACDEF, BACDFE, CBDAEF, CBDAFE, DCABEF, DCABFE). A washout period of at least 7 days between subsequent study drug administrations on Day 1 of each treatment period will be maintained.
  • Experimental: Part 2 (Optional)
    Optional Part 2 will only be performed if considered to be warranted by the sponsor based on the preliminary pharmacokinetic (PK) analysis of the results from Part 1. Participants will receive a single oral dose of seltorexant (20 mg) as 3 different formulations assigned to one of the either 6 or 4 treatment sequences under fasted or semi-fasted conditions. The treatment will be assigned in 1 of the 6 or 4 assigned sequences per treatment period that is either Period 1 to 6 or Period 1 to 4).

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) when Compared for 3 Oral Tablet Formulations of Seltorexant [ Time Frame: Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
PRAHSSalt Lake CityUtah84124-

Find similar trials in Salt Lake City, UT

By research site
PRAHS· Salt Lake City, UT

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