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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 14C-aticaprant

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, NZ 9728
    • PRA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 14C-aticaprant; 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; 14C-aticaprant will be administered orally as capsule on Day 1.; 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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): March 2, 2022
• Study Completion (Actual): March 2, 2022

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Aticaprant
• Other Study ID Numbers: CR109135; 2021-005130-42 (EudraCT Number); 67953964MDD1002 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No