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

NCT03494907 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-04-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2018-08-13
Completion
2018-08-13
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03494907 on ClinicalTrials.gov