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

NCT ID: NCT02674295

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-08-31

Brief 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.

Detailed Description

This is a single-center, open-label (identity of study drug will be known to participant and study staff), single-dose, parallel-group study. The study consist of Screening Phase (Days -21 to -2), Open-label treatment Phase (Day -1 up to Day 8) and End of Study (9 to 13 days after last study assessment). The total duration of study from the Screening Phase through Follow-up, is 37-41 days. Participants will be assigned to 1 of the two groups (Cohort 1 and Cohort 2) during the treatment phase. The participants will be primarily evaluated to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes. Participants' safety will be monitored throughout the study.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cohort 1

50 milligram (mg) of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration.

Group Type: EXPERIMENTAL

Esketamine 50 mg

Intervention Type: DRUG

50 mg of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration (80 mL total volume)

Cohort 2

20 mg of intravenous esketamine in 30 milliliter (mL), fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion.

Group Type: EXPERIMENTAL

Esketamine 20 mg

Intervention Type: DRUG

20 mg of intravenous esketamine in 30 mL, fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion.

Interventions

Esketamine 50 mg

50 mg of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration (80 mL total volume)

Intervention Type: DRUG

Esketamine 20 mg

20 mg of intravenous esketamine in 30 mL, fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

54135419TRD1016

Identifier Type: OTHER

Identifier Source: secondary_id

CR108107

Identifier Type: -

Identifier Source: org_study_id