drugset / Trial / NCT03682380

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

NCT03682380

Phase 1 Completed 151 enrolled Janssen Research & Development, LLC
RandomizedCrossoverOpen-labelOther

Summary

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.

Timeline

Start
2018-10-01
Primary completion
2019-08-23
Completion
2019-08-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Seltorexant Small molecule Oral

Indications

No indication recorded.