A Study of 14C JNJ-67953964 in Healthy Adult Male Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacokinetic (PK), metabolism, and routes of excretion of aticaprant and its metabolites in excreta and in plasma after a single oral dose 14C-aticaprant in healthy adult male participants.

Official Title
-----------------
A Phase 1, Open Label Study to Characterize the Absorption, Metabolism, and Excretion of 14C JNJ-67953964 After a Single Dose in Healthy Adult Male Participants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: 14C-aticaprant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy on the basis of physical examination, medical history (screening only), vital signs, and electrocardiogram (ECG) performed at screening and admission to the study site on Day -1. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable Body weight not less than 50 kilograms (kg) and body mass index (BMI; weight [kg]/height^2 [m^2]) within the range of 18.0 to 29.9 kilogram per meter square (kg/m^2) (inclusive) Blood pressure (after the participant is supine for 5 minutes) between 90 millimeters of mercury (mmHg) and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening and Day -1 A 12-lead ECG consistent with normal cardiac conduction and function, at screening and Day -1, including: sinus rhythm; pulse rate between 40 and 100 beat per minutes (bpm), extremes included; QTc interval less than or equal to (<=) 450 milliseconds (ms) for men; QRS interval of less than (<) 120 ms; PR interval < 210 ms; morphology consistent with healthy cardiac conduction and function Non-smokers (not smoked for 3 months prior to screening) Exclusion Criteria: History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin, or malignancy, which is considered cured with minimal risk of recurrence) Known allergies, hypersensitivity, or intolerance to aticaprant or its excipients History of clinically significant (example: in the opinion of the investigator) drug and/or food allergies Participant has presence of left bundle branch block, atrioventricular block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator Anatomical (nasal) abnormalities which may make the placement of the nasoduodenal tube difficult (only for participants with duodenal sampling)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 14C-aticaprant<br>Participants in Group A (without duodenal fluid collection) and Group B (with duodenal fluid collection) will receive a single oral dose of 14C-aticaprant on Day 1. | Drug: 14C-aticaprant<br>* 14C-aticaprant will be administered orally as capsule on Day 1.<br>* Other names: JNJ-67953964;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentrations of Aticaprant and its Metabolite M3 | Plasma samples will be analyzed to determine concentrations of aticaprant and its Metabolite M3 using a validated, specific, and sensitive liquid chromatography (LC)-mass spectrometry (MS)/MS method. | Up to Day 39 | 
| Duodenal Concentrations of Aticaprant and its Metabolite M3 | Duodenal fluid samples will be analyzed to determine concentrations of aticaprant and its Metabolite M3 using a, specific, and sensitive (LC-MS/MS) method. | Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1 | 
| Urine Concentration of Aticaprant and its Metabolites M3 | Urine samples will be analyzed to determine concentrations of aticaprant and its metabolite M3 using a, specific, and sensitive (LC-MS/MS) method. | Pre-dose up to Day 32 | 
| Total Radioactivity Concentration of 14C-aticaprant in Whole Blood | Total radioactivity concentration of 14C-aticaprant in whole blood will be performed via liquid scintillation counting. | Pre-dose up to Day 14 | 
| Total Radioactivity Concentration of 14C-aticaprant in Plasma | Total radioactivity concentration of 14C-aticaprant in plasma will be performed via liquid scintillation counting. | Pre-dose up to Day 14 | 
| Total Radioactivity Concentration of 14C-aticaprant in Duodenal Fluid | Total radioactivity concentration of 14C-aticaprant in duodenal fluid samples will be performed via liquid scintillation counting. | Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1 | 
| Amount of Total Radioactivity of 14C-aticaprant in Urine | Amount of total radioactivity of 14C-aticaprant in urine will be performed via liquid scintillation counting. | Up to Day 32 | 
| Amount of Total Radioactivity of 14C-aticaprant in Feces | Amount of total radioactivity of 14C-aticaprant in feces will be performed via liquid scintillation counting. | Up to Day 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. | Up to Day 67 | 
| Number of Participants with Clinical Laboratory Abnormalities | Number of participants with clinical laboratory abnormalities (including serum chemistry, hematology and urinalysis) will be reported. | Up to Day 67 | 
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Number of participants with ECG abnormalities will be reported. | Up to Day 67 | 
| Number of Participants with Vital Signs Abnormalities | Number of participants with vital signs abnormalities (including body temperature, pulse rate, respiratory rate, blood pressure [systolic and diastolic]) will be reported. | Up to Day 67 | 
| Number of Participants with Physical Examination Abnormalities | Number of participants with physical examination abnormalities will be reported. | Up to Day 67 |