HealthyPhase 1NCT04791332
A Study of JNJ-67953964 in Healthy Japanese Adult Male Participants
A Phase 1 study testing JNJ-67953964 in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-67953964
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 30 Apr 2021to 28 Jul 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be healthy on the basis of physical and neurological examination, medical history, vital signs, and 12- lead electrocardiogram (ECG) (QT corrected according to Fridericia's formula [QTcF] less than or equal to [<=] 450 milliseconds [msec]) performed at screening and admission to the clinical site. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable. The presence of left bundle branch block, atrioventricular (AV) block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator will lead to exclusion
- Participant must be healthy on the basis of clinical laboratory tests performed at screening and baseline (Day -1). 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 once during the screening phase upon discretion of the investigator. At screening and baseline (Day -1), alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, and bilirubin must be within normal ranges. 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 according to both the investigator and to the study responsible physician (SRP), are acceptable. This determination must be recorded in the participant's source documents and initialed by the investigator
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Single Ascending and Multiple Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-67953964 in Healthy Japanese Adult Male Participants
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
- Being tested
- JNJ-67953964, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-67953964Drug
JNJ-67953964 capsule will be administered orally.
PlaceboDrug
Matching placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: JNJ-67953964; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start30 Apr 2021
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791332
- Sponsor's protocol ID
- CR108983
- Other IDs
- 67953964EDI1002
- Status last verified
- Apr 2025
- First submitted
- 9 Mar 2021
- Last updated
- 28 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 and 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Single Ascending and Multiple Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-67953964 in Healthy Japanese Adult Male Participants
- ClinicalTrials.gov ID
- NCT04791332
- Acronym / sponsor ID
- CR108983
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Dose Cohort: Cohort 1 and 2 | Experimental | Drug: JNJ-67953964, Drug: PlaceboParticipants will receive a single oral dose of JNJ-67953964 or a matching placebo on Day 1. |
| Multiple Dose Cohort: Cohort 3 | Experimental | Drug: JNJ-67953964, Drug: PlaceboParticipants will receive multiple oral dose of JNJ-67953964 once daily or a matching placebo up to Day 14. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant must be healthy on the basis of physical and neurological examination, medical history, vital signs, and 12- lead electrocardiogram (ECG) (QT corrected according to Fridericia's formula [QTcF] less than or equal to [<=] 450 milliseconds [msec]) performed at screening and admission to the clinical site. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable. The presence of left bundle branch block, atrioventricular (AV) block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator will lead to exclusion
- Participant must be healthy on the basis of clinical laboratory tests performed at screening and baseline (Day -1). 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 once during the screening phase upon discretion of the investigator. At screening and baseline (Day -1), alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, and bilirubin must be within normal ranges. 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 according to both the investigator and to the study responsible physician (SRP), are acceptable. This determination must be recorded in the participant's source documents and initialed by the investigator
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-67953964JNJ-67953964 capsule will be administered orally. | Drug | Multiple Dose Cohort: Cohort 3, Single Dose Cohort: Cohort 1 and 2 |
| PlaceboMatching placebo will be administered orally. | Drug | Multiple Dose Cohort: Cohort 3, Single Dose Cohort: Cohort 1 and 2 |
Primary outcome
Number of Participants with Adverse Events (AEs) for Single- dose Cohort
Time frame: Up to 5 weeks
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.
Number of Participants with AEs for Multiple- dose Cohort
Time frame: Up to 7 weeks
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.
Plasma Concentration of JNJ-67953964 for Single- dose Cohort
Time frame: Up to Day 5
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.
Plasma Concentration of JNJ-67953964 for Multiple- dose Cohort
Time frame: Up to Day 17
Plasma samples will be analyzed to determine concentrations of JNJ-67953964 using a fully validated LC-MS/MS method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-67953964 in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.
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: finished, as of the sponsor's last update on 28 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 Japan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Adverse Events (AEs) for Single- dose Cohort (time frame: Up to 5 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2025.