A Study of JNJ-67953964 in Healthy Japanese Adult Male Participants

NCT04791332 | Completed Phase 1

• 2 other identifiers: CR10898367953964EDI1002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single- and multiple-dose oral administration of JNJ-67953964 in healthy Japanese adult male participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Adverse Events (AEs) for Single- dose Cohort

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  Up to 5 weeks

• Number of Participants with AEs for Multiple- dose Cohort

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  Up to 7 weeks

• Plasma Concentration of JNJ-67953964 for Single- dose Cohort

  Plasma samples will be analyzed to determine concentrations of JNJ-67953964 using a fully validated liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) method.

  Up to Day 5

• Plasma Concentration of JNJ-67953964 for Multiple- dose Cohort

  Plasma samples will be analyzed to determine concentrations of JNJ-67953964 using a fully validated LC-MS/MS method.

  Up to Day 17

Study Arms (2)

Single Dose Cohort: Cohort 1 and 2

EXPERIMENTAL

Participants will receive a single oral dose of JNJ-67953964 or a matching placebo on Day 1.

Drug: JNJ-67953964; Drug: Placebo

Multiple Dose Cohort: Cohort 3

EXPERIMENTAL

Participants will receive multiple oral dose of JNJ-67953964 once daily or a matching placebo up to Day 14.

Drug: JNJ-67953964; Drug: Placebo

Interventions

JNJ-67953964 DRUG

JNJ-67953964 capsule will be administered orally.

Multiple Dose Cohort: Cohort 3; Single Dose Cohort: Cohort 1 and 2

Placebo DRUG

Matching placebo will be administered orally.

Multiple Dose Cohort: Cohort 3; Single Dose Cohort: Cohort 1 and 2

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI; weight in kilogram divided by the square of height in meters between 18 and 30 kilogram per meter square (kg/m\^2) (inclusive), and body weight not less than 50 kg at screening and on Day -1
• Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control example, a condom for the duration of the study plus 3 months after receiving the last dose of study intervention, and all men must not donate sperm during the study and for 3 months after receiving the last dose of study intervention. In addition, their female partners should also use an additional method of birth control (which may include a hormonal method, an intrauterine device \[IUD\] or an intrauterine system \[IUS\]) for at least the same duration
• Blood pressure (after the participant is supine for 5 minutes) between 90 and 139 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 89 mm Hg diastolic at screening and on Day -1. If blood pressure is out of range, up to 2 repeated assessments are permitted

You may not qualify if:

• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency thyroid disease, Parkinson's disease, infection including participants with a positive of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) specific test on Day -8 to -1, or any other illness that the Investigator considers should exclude the participant
• Known allergies, hypersensitivity, or intolerance to JNJ-67953964 and its excipients
• History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 6 months before screening or positive test result(s) for alcohol, nicotine metabolites and/or drugs of abuse (opiates \[including methadone\], cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, ecstasy, and benzodiazepines) at screening or at admission to the study center
• History of clinically significant drug and/or food allergies
• Clinically significant acute illness within 7 days prior to study intervention administration

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Sumida Hospital

Tokyo, 130-0004, Japan

Location

MeSH Terms

Interventions

Aticaprant

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 10, 2021
• Study Start: April 30, 2021
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: April 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)