A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes in healthy male participants.

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

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Esketamine

Criteria

Inclusion Criteria:

• Participants willing to adhere to the prohibitions and restrictions specified in the protocol

• If a man who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (example, vasectomy, double-barrier, partner using effective contraception) for 3 months following administration of study drug

• Participants with body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than 50 kg

• Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. Note: Average from 3 supine measurements will be used at screening visit

• A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including: Sinus rhythm; Heart rate between 45 and 90 beats per minute (bpm); QTc interval less than or equal to (<=)450 milliseconds (ms); QRS interval of <110 ms; PR interval <200 ms; Morphology consistent with healthy cardiac conduction and function

Exclusion Criteria:

• Participants diagnosed with a current or previous psychiatric or bipolar disorder, as assessed by the investigator, will not be permitted to participate in the study

• Current suicidal or homicidal ideation/intent/behavior as assessed by Columbia Suicide Severity Rating Scale (C-SSRS) at screening

• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center on Day -1 as deemed appropriate by the investigator

• Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening or Day -1, and as deemed appropriate by the investigator

• Use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before study drug administration is scheduled, except for acetaminophen