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A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants

NCT02737605 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-04-11

No results posted yet for this study

Summary

The purpose of the study is to assess the effects of esketamine on QT/QTc intervals and electrocardiogram (ECG) morphology at therapeutic exposures of esketamine and noresketamine (intranasal administration) and supratherapeutic exposures of esketamine (intravenous administration) in healthy adults.

Conditions

  • Healthy

Interventions

DRUG

Intranasal Esketamine

Participants will receive 84 mg intranasal esketamine as 3 devices, each with 28 mg esketamine.

DRUG

Intravenous Esketamine

Participants will receive 0.8 milligram per kilogram body weight esketamine, 40 minutes, intravenous infusion.

DRUG

Moxifloxacin

Participants will receive 400 mg Moxifloxacin orally.

DRUG

Oral Placebo

Participants will receive matching placebo orally.

DRUG

Intravenous Placebo

Participants will receive placebo 40 minutes, intravenous infusion.

DRUG

Intranasal Placebo

Participants will receive intranasal placebo (1 spray in each nostril at 0, 5, and 10 minutes).

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
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2017-02-23
Completion
2017-02-23

Countries

  • Germany

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 NCT02737605 on ClinicalTrials.gov