Clinical trial NCT02674295: A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants
Official title: An Open-label, Single-dose Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
JNJ-54135419
Esketamine
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Characterisation and Identification of 14C-esketamine Metabolites (Metabolic Profile)
timeFrame: upto 168 hour post-dose
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs) or Serious Adverse Events
timeFrame: up to 41 days
Other outcomes:
Locations:
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: