A Study of JNJ-64140284 in Healthy Male Participants (AMPAR)

April 25, 2025 updated by: Janssen Pharmaceutica N.V., Belgium

A 3-Part, Randomized, Placebo-controlled, Double-blind, Single Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64140284 in Healthy Male Participants

The purpose of the study is to investigate and compare the pharmacokinetic (PK) profiles of a single dose of two solid dosage formulations of JNJ-64140284 in plasma and urine in healthy male participants under fed and fasting conditions; and to investigate the safety and tolerability of two solid dosage formulations of JNJ 64140284 versus placebo after single oral dose administration in healthy male participants under fed and fasting conditions in Part 1; to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration (or 1 divided dose, if applicable) (ascending dose levels) in healthy male participants; and to characterize the PK of a single dose (or 1 divided dose, if applicable) of JNJ-64140284 in plasma in healthy male participants in Part 2; and to investigate the effect of food on the PK of a single (or 1 divided dose, if applicable) therapeutic relevant dose of JNJ 64140284 in healthy male participants; and to investigate the safety and tolerability of JNJ-64140284 versus placebo after single oral dose administration at a therapeutic relevant dose (or 1 divided dose, if applicable) in fed conditions in Part 3.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2060
        • SGS Life Science Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 54 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Participant has a body mass index (BMI) between 18.0 and 29.9 kilograms per square meters (kg/m^2) inclusive
  • Participant must be healthy on the basis of clinical laboratory tests. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed. The participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Participant must be healthy on the basis of physical and neurological examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) (means of triplicate ECG, incl. QTcF less than or equal to [<=] 450 milliseconds [msec] for males). Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable
  • A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person and must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 3 months after receiving the last dose of study intervention
  • Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion criteria:

  • Participant has history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
  • Participant has a Left Bundle Branch Block (LBBB), atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator (ICD)
  • Participant has a history of suicidal ideation or a family history of suicide
  • Participant has a history of major depressive disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria
  • Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti HCV at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Cohort 1 (Placebo or JNJ-64140284)
Participants will receive matching placebo in Treatment A or JNJ-64140284 (as formulation 1) in Treatment B or JNJ-64140284 (as formulation 2) in Treatment C on Day 1 under fasted condition. Participants will receive treatment in either of the 6 treatment sequences (ABC, BCA, CAB, CBA, ACB or BAC) in Period 1, 2, or 3 under fasted condition. Each period is separated by washout period of 5 days.
Drug: JNJ-64140284
Participant will receive JNJ-64140284 formulation 1 or 2 under fasting or fed condition.
Drug: Placebo
Participant will receive matching placebo.
Experimental: Part 1: Cohort 2 (Placebo or JNJ-64140284)
Participants will receive matching placebo (Treatment D) or JNJ- 64140284 (as formulation 1) in Treatment E or JNJ-64140284 (as formulation 2) in Treatment F. Participants will receive treatment in either of 6 treatment sequence (DEF, EFD, FDE, FED, DFE or EDF) in Period 1, 2, or 3 under fed condition. Each period is separated by washout period of 5 days.
Drug: JNJ-64140284
Participant will receive JNJ-64140284 formulation 1 or 2 under fasting or fed condition.
Drug: Placebo
Participant will receive matching placebo.
Experimental: Part 2: Cohorts 1-7 (JNJ-64140284 or Placebo)
Participants will receive JNJ 64140284 formulation 1 or 2 or matching placebo under fasting condition in Cohorts 1 to 7 on Day 1.
Drug: JNJ-64140284
Participant will receive JNJ-64140284 formulation 1 or 2 under fasting or fed condition.
Drug: Placebo
Participant will receive matching placebo.
Experimental: Part 3: Cohorts 1-2 (JNJ-64140284 or placebo)
Participants will receive JNJ-64140284 formulation 1 or 2 or matching placebo under fed condition in Cohorts 1 to 2 on Day 1.
Drug: JNJ-64140284
Participant will receive JNJ-64140284 formulation 1 or 2 under fasting or fed condition.
Drug: Placebo
Participant will receive matching placebo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Plasma Concentration of JNJ-64140284
Time Frame: Pre-dose, Day 1, 2, 3 and Day 4
Plasma samples will be analyzed to determine concentrations of JNJ-64140284 under fed and fasting conditions using a validated, specific and sensitive liquid chromatography-mass spectrometry (LC-MS/MS).
Pre-dose, Day 1, 2, 3 and Day 4
Part 1: Urine Concentration of JNJ-64140284
Time Frame: Pre-dose, Day 1, 2, 3 and Day 4
Urine samples will be analyzed to determine concentrations of JNJ-64140284 in renal clearance.
Pre-dose, Day 1, 2, 3 and Day 4
Part 2: Plasma Concentration After Single Dose Administration of JNJ-64140284
Time Frame: Pre-dose, Day 1, 2, 3 and Day 4
Plasma samples will be analyzed to determine concentrations of JNJ-64140284 under fed and fasting conditions using a validated, specific and sensitive liquid chromatography-mass spectrometry (LC-MS/MS).
Pre-dose, Day 1, 2, 3 and Day 4
Part 3: Ratio of Area Under Plasma Concentration Curve (AUC) and Maximum Plasma Concentration (Cmax)
Time Frame: Pre-dose, Day 1, 2, 3 and Day 4
Ratio of geometric means for pharmacokinetics (PK) parameters (AUCs and Cmax) of JNJ 64140284 (fed versus fasted condition) will be analyzed to determine the food effect.
Pre-dose, Day 1, 2, 3 and Day 4
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability: Part 1, Part 2, and Part 3
Time Frame: Up to 1.5 years
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
Up to 1.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bond & Lader Visual Analogue Scale (VAS) Score: Part 1 and Part 2
Time Frame: Day -1, 1, 2 and Day 3
The VAS is a participant rated scale, made up of 16 (items) pairs of alternative descriptors of mood and attention at either end of a 10-centimeter (cm) line. The item score ranges from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria.
Day -1, 1, 2 and Day 3
Karolinska Sleepiness Scale (KSS) Score: Part 1 and Part 2
Time Frame: Day -1, 1, 2 and Day 3
The KSS is a participant-reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 'extremely alert' (1) to 'very sleepy, great effort to keep awake, fighting sleep' (9).
Day -1, 1, 2 and Day 3
Body Sway
Time Frame: Day -1, 1, 2 and Day 3
Body sway will be used to measure body movements, providing a measure of postural stability. The method has been used to demonstrate effects of sleep deprivation, alcohol, and benzodiazepines. It will be measured either using a stabilometric platform or a pot string meter based on the Wright ataxiameter.
Day -1, 1, 2 and Day 3
Part 2: Pharmacodynamics (PD) as Assessed by Cognitive Test Battery: Detection Task (DET)
Time Frame: Day -1, 1, 2 and Day 3
DET is a measure of psychomotor function. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.
Day -1, 1, 2 and Day 3
Part 2: PD as Assessed by Cognitive Test Battery: Identification Task (IDN)
Time Frame: Day -1, 1, 2 and Day 3
IDN is a measure of attention. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.
Day -1, 1, 2 and Day 3
Part 2: PD as Assessed by Cognitive Test Battery: One Card Learning Task (OCL)
Time Frame: Day -1, 1, 2 and Day 3
OCL is a measure of visual learning. The test measures accuracy of performance; arcsine transformation of the square root of the proportion of correct responses. Higher score indicates better performance.
Day -1, 1, 2 and Day 3
Part 2: PD as Assessed by Cognitive Test Battery: One Back Task (ONB)
Time Frame: Day -1, 1, 2 and Day 3
ONB is a measure of working memory. The test measures speed of performance; mean of the log10 transformed reaction times for correct responses. Lower score indicates better performance.
Day -1, 1, 2 and Day 3
Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test (GMLT)
Time Frame: Day -1, 1, 2 and Day 3
GMLT is a measure of executive function and spatial learning. The test measures total number of errors made while locating and learning 28 step pathway hidden beneath a 10*10 grid on 5 consecutive trials during a single session. Lower score indicates better performance.
Day -1, 1, 2 and Day 3
Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test (ISLT)
Time Frame: Day -1, 1, 2 and Day 3
The ISLT is a measure of verbal learning. The test measures total number of correct responses remembering the word list on 3 consecutive trials at a single assessment. Higher score indicates better performance.
Day -1, 1, 2 and Day 3
Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test delayed (ISLT-D)
Time Frame: Day -1, 1, 2 and Day 3
ISLT-D is a measure of delayed verbal memory. The test measures total number of correct responses recalling the word list learned initially. Higher score indicates better performance.
Day -1, 1, 2 and Day 3
Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test delayed (GMLT-D)
Time Frame: Day -1, 1, 2 and Day 3
GMLT delayed recall is a measure of delayed spatial memory. The test measures number of errors made while locating 28 step pathway hidden beneath a 10*10 grid after a delay. Lower score indicates better performance.
Day -1, 1, 2 and Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Pharmaceutica N.V., Belgium

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial, Janssen Pharmaceutica N.V., Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108866
  • 2020-002616-40 (EudraCT Number)
  • 64140284EDI1005 (Other Identifier: Janssen Pharmaceutica N.V., Belgium)

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on JNJ-64140284

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings