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

NCT05197062 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1091352021-005130-4267953964MDD1002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• Number of Participants with Adverse Events (AEs)

  Up to Day 67

• Number of Participants with Clinical Laboratory Abnormalities

  Up to Day 67

• Number of Participants with Electrocardiogram (ECG) Abnormalities

  Up to Day 67

• Number of Participants with Vital Signs Abnormalities

  Up to Day 67

• Number of Participants with Physical Examination Abnormalities

  Up to Day 67

Study Arms (1)

14C-aticaprant

EXPERIMENTAL

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

Interventions

14C-aticaprant DRUG

14C-aticaprant will be administered orally as capsule on Day 1.

Also known as: JNJ-67953964

14C-aticaprant

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

PRA Health Sciences

Groningen, NZ 9728, Netherlands

Location

MeSH Terms

Interventions

Aticaprant

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 19, 2022
• Study Start: January 14, 2022
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)