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A Pharmacokinetic, Safety and Tolerability Study of Esketamine in Healthy Elderly and Adult Participants

NCT02129088 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2014-07-25

No results posted yet for this study

Summary

The purpose of this study is to compare the pharmacokinetics (explores what the body does to the drug), safety and tolerability of esketamine, administered intranasally (administered through the nose) in healthy elderly (Cohort 1) and healthy adult (Cohort 2) participants.

Conditions

  • Healthy

Interventions

DRUG

Esketamine

Esketamine 14 mg will be self-administered by participants as intranasal spray into each nostril on Day 1 to cohort 1 and cohort 2 in a fixed sequence.

DRUG

Placebo

Placebo will be self-administered as intranasal spray by participants after 5 and 10 minutes of esketamine administration into each nostril on Day 1 of Treatment period 2 to Cohort 2.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

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 NCT02129088 on ClinicalTrials.gov