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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Esketamine; Pharmaceutical Solutions; Triazolam

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