CompletedPhase 1ketamine

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants

Sponsored by Janssen Research & Development, LLC

NCT ID
NCT01780259
Target Enrollment
58 participants
Start Date
2012-12
Est. Completion
2013-05

About This Study

The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to the medication) of intranasally (through the nose) administered esketamine in healthy participants.

Conditions Studied

Healthy

Interventions

  • Esketamine
  • Placebo
  • Triazolam

Eligibility

Age:18 Years - 55 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria:

* Blood pressure between 90 and 145 mmHg systolic and no higher than 90 mmHg diastolic
* A 12-lead electrocardiogram consistent with normal cardiac conduction and function
* Agree to protocol-defined method of contraception
* Comfortable with self-administration of intranasal medication

Exclusion Criteria:

* History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; renal or hepatic insufficiency; thyroid disease; neurologic or psychiatric disease, asthma
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center
* Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram at screening or at admission to the study center
* Known allergy to heparin or history of heparin-induced thrombocytopenia

Study Locations (1)

Merksem, Belgium

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source