NCT03494907

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

A Randomized, Double-blind, Placebo- and Positive-controlled, Single-dose, 4-way Crossover Study to Evaluate the Effects of Seltorexant (JNJ-42847922) on Electrocardiogram Intervals in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2018-04-09
• Primary completion: 2018-08-13
• Completion: 2018-08-13
• First posted: 2018-04-11
• Last updated: 2025-04-27

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study