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HealthyPhase 1AMPARNCT04566926

A Study of JNJ-64140284 in Healthy Male Participants

A Phase 1 study testing JNJ-64140284 in people with Healthy, run by Janssen Pharmaceutica N.V., Belgium at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 54 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JNJ-64140284
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteBelgium
Study dates
29 Sep 2020to 5 Apr 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 54 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • SGS Life Science Services

    Antwerp, 2060

Other trials in Belgium

About this study

Official title: 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.

Conditions
Healthy
Being tested
JNJ-64140284, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-64140284Drug

    Participant will receive JNJ-64140284 formulation 1 or 2 under fasting or fed condition.

  • PlaceboDrug

    Participant will receive matching placebo.

Study groups in NCT04566926
Study groupRoleWhat they receive
Part 1: Cohort 1 (Placebo or JNJ-64140284)ExperimentalParticipants 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.
Receives: Drug: JNJ-64140284; Drug: Placebo
Part 1: Cohort 2 (Placebo or JNJ-64140284)ExperimentalParticipants 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.
Receives: Drug: JNJ-64140284; Drug: Placebo
Part 2: Cohorts 1-7 (JNJ-64140284 or Placebo)ExperimentalParticipants will receive JNJ 64140284 formulation 1 or 2 or matching placebo under fasting condition in Cohorts 1 to 7 on Day 1.
Receives: Drug: JNJ-64140284; Drug: Placebo
Part 3: Cohorts 1-2 (JNJ-64140284 or placebo)ExperimentalParticipants will receive JNJ-64140284 formulation 1 or 2 or matching placebo under fed condition in Cohorts 1 to 2 on Day 1.
Receives: Drug: JNJ-64140284; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Plasma Concentration of JNJ-64140284

    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).

    Measured: Pre-dose, Day 1, 2, 3 and Day 4

  2. Part 1: Urine Concentration of JNJ-64140284

    Urine samples will be analyzed to determine concentrations of JNJ-64140284 in renal clearance.

    Measured: Pre-dose, Day 1, 2, 3 and Day 4

  3. Part 2: Plasma Concentration After Single Dose Administration of JNJ-64140284

    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).

    Measured: Pre-dose, Day 1, 2, 3 and Day 4

  4. Part 3: Ratio of Area Under Plasma Concentration Curve (AUC) and Maximum Plasma Concentration (Cmax)

    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.

    Measured: Pre-dose, Day 1, 2, 3 and Day 4

  5. Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability: Part 1, Part 2, and Part 3

    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.

    Measured: Up to 1.5 years

Secondary outcomes (11)

  1. Bond & Lader Visual Analogue Scale (VAS) Score: Part 1 and Part 2

    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.

    Measured: Day -1, 1, 2 and Day 3

  2. Karolinska Sleepiness Scale (KSS) Score: Part 1 and Part 2

    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).

    Measured: Day -1, 1, 2 and Day 3

  3. Body Sway

    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.

    Measured: Day -1, 1, 2 and Day 3

  4. Part 2: Pharmacodynamics (PD) as Assessed by Cognitive Test Battery: Detection Task (DET)

    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.

    Measured: Day -1, 1, 2 and Day 3

  5. Part 2: PD as Assessed by Cognitive Test Battery: Identification Task (IDN)

    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.

    Measured: Day -1, 1, 2 and Day 3

  6. Part 2: PD as Assessed by Cognitive Test Battery: One Card Learning Task (OCL)

    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.

    Measured: Day -1, 1, 2 and Day 3

  7. Part 2: PD as Assessed by Cognitive Test Battery: One Back Task (ONB)

    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.

    Measured: Day -1, 1, 2 and Day 3

  8. Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test (GMLT)

    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.

    Measured: Day -1, 1, 2 and Day 3

  9. Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test (ISLT)

    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.

    Measured: Day -1, 1, 2 and Day 3

  10. Part 2: PD as Assessed by Cognitive Test Battery: International Shopping List Test delayed (ISLT-D)

    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.

    Measured: Day -1, 1, 2 and Day 3

  11. Part 2: PD as Assessed by Cognitive Test Battery: Groton Maze Learning Test delayed (GMLT-D)

    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.

    Measured: Day -1, 1, 2 and Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2020
  2. Study start29 Sep 2020
  3. Primary completion5 Apr 2021
  4. Study completion5 Apr 2021

Why it stopped: business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04566926
Sponsor's protocol ID
CR108866
Other IDs
2020-002616-40, 64140284EDI1005
Acronym
AMPAR
Status last verified
Apr 2025
First submitted
24 Sep 2020
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-64140284 in people with Healthy, run by Janssen Pharmaceutica N.V., Belgium at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: business decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Plasma Concentration of JNJ-64140284 (time frame: Pre-dose, Day 1, 2, 3 and Day 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04566926.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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