HealthyPhase 1NCT03915886

A Study of JNJ-64530440 in Healthy Japanese Male Participants

A Phase 1 study testing JNJ-0440 in people with Healthy, run by Janssen Pharmaceutical K.K. at 1 site in Japan.

Terminated

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

Trial summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-64530440 (JNJ-0440) in healthy Japanese adult male participants after single oral dose administration with ascending dose design. 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-0440
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteJapan
Study dates: 15 Apr 2019to 17 Jul 2019
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

Body mass index (BMI; weight [kg]/height^2 [m]^2) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 50 kilogram (kg), at time of screening
Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities 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
Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study site. If the results of the biochemistry panel including liver enzymes, other specific tests, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if these are grade 1 abnormal values and 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
Blood pressure (after the participants has been supine for 5 minutes) between 90 and 140 millimeter of Mercury (mm Hg) systolic, inclusive, and no higher than 90 mm Hg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
Must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the study drug

Who cannot join

Any history of confirmed clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening or at admission to the study site as deemed appropriate by the investigator
History of confirmed clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
Known allergy to heparin or history of heparin induced thrombocytopenia
History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as hallucinogens, barbiturates, opiates, opioids, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening or at admission to the study site

Trial locations and contacts

1 site in 1 country.

Japan1 site

Sumida Hospital
Tokyo, 130-0004

Other trials in Japan

About this study

Official title: A Double-blind, Placebo-controlled, Randomized, Single Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64530440 in Healthy Japanese Male Subjects

Conditions: Healthy
Being tested: JNJ-0440, Placebo

What participants receive

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

JNJ-0440Drug
JNJ-0440 tablets will be administered orally.
PlaceboDrug
Matching placebo tablets will be administered orally.

Study groups in NCT03915886
Study group	Role	What they receive
JNJ-0440 (Low Dose) or Placebo	Experimental	Participants will receive single oral dose (low) of JNJ-0440 or matching placebo under fed conditions. The dose will be escalated based on the preliminary safety data from the preceding cohort as per sponsor and investigator discretion. Receives: Drug: JNJ-0440; Drug: Placebo
JNJ-0440 (Medium Dose) or Placebo	Experimental	Participants will receive single oral dose (medium) of JNJ-0440 or matching placebo under fed conditions. The dose will be escalated based on the preliminary safety data from the preceding cohort as per sponsor and investigator discretion. Receives: Drug: JNJ-0440; Drug: Placebo
JNJ-0440 (High Dose) or Placebo	Experimental	Participants will receive single oral dose (high) of JNJ-0440 or matching placebo under fed conditions. Receives: Drug: JNJ-0440; 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) as a Measure of Safety and Tolerability
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 agent under study.
Measured: Approximately up to 37 days
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-0440
Cmax is defined as the maximum observed plasma analyte concentration.
Measured: Up to follow-up visit (approximately up to Day 9)
Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-0440
Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.
Measured: Up to follow-up visit (approximately up to Day 9)
Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours Postdose (AUC [0- 24h]) of JNJ-0440
AUC(0-24h) is area under the plasma concentration-time curve from time zero to 24 hours, calculated by linear-linear trapezoidal summation.
Measured: Up to follow-up visit (approximately up to Day 9)
Area Under the Plasma Concentration-time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0- Last]) of JNJ-0440
AUC(0-Last) is area under the plasma concentration-time curve from time zero to time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.
Measured: Up to follow-up visit (approximately up to Day 9)
Area Under the Plasma Concentration-time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-0440
AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-below quantification limit) concentration.
Measured: Up to follow-up visit (approximately up to Day 9)
Apparent Terminal Elimination Rate Constant (Lambda[z]) of JNJ-0440
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Measured: Up to follow-up visit (approximately up to Day 9)
Apparent Terminal Elimination Half-Life (t1/2) of JNJ-0440
The t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic analyte concentration time curve, and is calculated as 0.693/lambda(z).
Measured: Up to follow-up visit (approximately up to Day 9)
Apparent Volume of Distribution (Vdz/F)
The Vdz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution based on the terminal phase after extravascular administration, uncorrected for absolute bioavailability and calculated as dose/(lambda (z)*AUC[0-infinity]).
Measured: Up to follow-up visit (approximately up to Day 9)
Apparent Total Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent total clearance of drug after extravascular administration, uncorrected for absolute bioavailability, calculated as dose/AUC(0-infinity).
Measured: Up to follow-up visit (approximately up to Day 9)
Amount of JNJ-0440 Excreted in Urine within the Time Interval x to y (Ae[x-y])
Ae(x-y) is the amount of JNJ-0440 excreted into urine for the collection interval from x to y hours, where x and y are the start and end times of the interval, respectively, calculated by multiplying the urinary volume with the urinary concentration for that interval.
Measured: Up to 72 hours postdose
Cumulative Urinary Recovery (Ae[0-x])
Ae(0-x) is the sum of Ae values for all collection intervals up to 72 hours postdose.
Measured: Up to 72 hours postdose
Total Cumulative Urinary Recovery (Ae[total])
Ae(total) is the sum of Ae values for all collection intervals.
Measured: Up to 72 hours postdose
Percentage of JNJ-0440 Excreted in Urine (Ae%dose[0-x])
The Ae%dose(0-x) is the percentage of cumulative JNJ-0440 dose recovered into the urine for all collection intervals up to x hours postdose, calculated as (Ae/dose[0-x])∗100.
Measured: Up to 72 hours postdose
Percentage of JNJ-0440 Excreted in Urine (Ae%dose[total])
Ae%dose(total) is the percentage of total JNJ-0440 dose recovered into the urine for all collection intervals, calculated as (Ae/dose[total])∗100.
Measured: Up to 72 hours postdose
Renal Clearance (CLr) of JNJ-0440
The CLr is the renal clearance of the drug, calculated as Ae(total)/AUC(0-infinity).
Measured: Up to 72 hours postdose

Timeline

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

15 Apr 201917 Jul 2019

First posted16 Apr 2019
Study start15 Apr 2019
Primary completion17 Jul 2019
Study completion17 Jul 2019

Why it stopped: Stopped due to a strategic decision.

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: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03915886
Sponsor's protocol ID: CR108603
Other IDs: 64530440HEP1001
Status last verified: Jan 2025
First submitted: 12 Apr 2019
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Randomized, Single Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64530440 in Healthy Japanese Male Subjects
ClinicalTrials.gov ID: NCT03915886
Acronym / sponsor ID: CR108603
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Stopped due to a strategic decision.
Enrolment: 16 participants (actual)
Lead sponsor: Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
Collaborators: Janssen Research & Development, LLC
Study start: 15 Apr 2019 (actual)
Primary completion: 17 Jul 2019 (actual)
Study completion: 17 Jul 2019 (actual)
First posted: 16 Apr 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
JNJ-0440 (Low Dose) or Placebo	Experimental	Drug: JNJ-0440, Drug: PlaceboParticipants will receive single oral dose (low) of JNJ-0440 or matching placebo under fed conditions. The dose will be escalated based on the preliminary safety data from the preceding cohort as per sponsor and investigator discretion.
JNJ-0440 (Medium Dose) or Placebo	Experimental	Drug: JNJ-0440, Drug: PlaceboParticipants will receive single oral dose (medium) of JNJ-0440 or matching placebo under fed conditions. The dose will be escalated based on the preliminary safety data from the preceding cohort as per sponsor and investigator discretion.
JNJ-0440 (High Dose) or Placebo	Experimental	Drug: JNJ-0440, Drug: PlaceboParticipants will receive single oral dose (high) of JNJ-0440 or matching placebo under fed conditions.

Who may qualify

Ages: 20 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Body mass index (BMI; weight [kg]/height^2 [m]^2) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 50 kilogram (kg), at time of screening
Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities 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
Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study site. If the results of the biochemistry panel including liver enzymes, other specific tests, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if these are grade 1 abnormal values and 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
Blood pressure (after the participants has been supine for 5 minutes) between 90 and 140 millimeter of Mercury (mm Hg) systolic, inclusive, and no higher than 90 mm Hg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
Must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the study drug

Key exclusion criteria (5 listed)

Any history of confirmed clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening or at admission to the study site as deemed appropriate by the investigator
History of confirmed clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
Known allergy to heparin or history of heparin induced thrombocytopenia
History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as hallucinogens, barbiturates, opiates, opioids, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening or at admission to the study site

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-0440JNJ-0440 tablets will be administered orally.	Drug	JNJ-0440 (High Dose) or Placebo, JNJ-0440 (Low Dose) or Placebo, JNJ-0440 (Medium Dose) or Placebo
PlaceboMatching placebo tablets will be administered orally.	Drug	JNJ-0440 (High Dose) or Placebo, JNJ-0440 (Low Dose) or Placebo, JNJ-0440 (Medium Dose) or Placebo

Primary outcome

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Approximately up to 37 days
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 agent under study.
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-0440
Time frame: Up to follow-up visit (approximately up to Day 9)
Cmax is defined as the maximum observed plasma analyte concentration.
Actual Sampling Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax) of JNJ-0440
Time frame: Up to follow-up visit (approximately up to Day 9)
Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.
Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours Postdose (AUC [0- 24h]) of JNJ-0440
Time frame: Up to follow-up visit (approximately up to Day 9)
AUC(0-24h) is area under the plasma concentration-time curve from time zero to 24 hours, calculated by linear-linear trapezoidal summation.
Area Under the Plasma Concentration-time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0- Last]) of JNJ-0440
Time frame: Up to follow-up visit (approximately up to Day 9)
AUC(0-Last) is area under the plasma concentration-time curve from time zero to time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.
Area Under the Plasma Concentration-time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-0440
Time frame: Up to follow-up visit (approximately up to Day 9)
AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-below quantification limit) concentration.
Apparent Terminal Elimination Rate Constant (Lambda[z]) of JNJ-0440
Time frame: Up to follow-up visit (approximately up to Day 9)
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Apparent Terminal Elimination Half-Life (t1/2) of JNJ-0440
Time frame: Up to follow-up visit (approximately up to Day 9)
The t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic analyte concentration time curve, and is calculated as 0.693/lambda(z).
Apparent Volume of Distribution (Vdz/F)
Time frame: Up to follow-up visit (approximately up to Day 9)
The Vdz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution based on the terminal phase after extravascular administration, uncorrected for absolute bioavailability and calculated as dose/(lambda (z)*AUC[0-infinity]).
Apparent Total Clearance (CL/F)
Time frame: Up to follow-up visit (approximately up to Day 9)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent total clearance of drug after extravascular administration, uncorrected for absolute bioavailability, calculated as dose/AUC(0-infinity).
Amount of JNJ-0440 Excreted in Urine within the Time Interval x to y (Ae[x-y])
Time frame: Up to 72 hours postdose
Ae(x-y) is the amount of JNJ-0440 excreted into urine for the collection interval from x to y hours, where x and y are the start and end times of the interval, respectively, calculated by multiplying the urinary volume with the urinary concentration for that interval.
Cumulative Urinary Recovery (Ae[0-x])
Time frame: Up to 72 hours postdose
Ae(0-x) is the sum of Ae values for all collection intervals up to 72 hours postdose.
Total Cumulative Urinary Recovery (Ae[total])
Time frame: Up to 72 hours postdose
Ae(total) is the sum of Ae values for all collection intervals.
Percentage of JNJ-0440 Excreted in Urine (Ae%dose[0-x])
Time frame: Up to 72 hours postdose
The Ae%dose(0-x) is the percentage of cumulative JNJ-0440 dose recovered into the urine for all collection intervals up to x hours postdose, calculated as (Ae/dose[0-x])∗100.
Percentage of JNJ-0440 Excreted in Urine (Ae%dose[total])
Time frame: Up to 72 hours postdose
Ae%dose(total) is the percentage of total JNJ-0440 dose recovered into the urine for all collection intervals, calculated as (Ae/dose[total])∗100.
Renal Clearance (CLr) of JNJ-0440
Time frame: Up to 72 hours postdose
The CLr is the renal clearance of the drug, calculated as Ae(total)/AUC(0-infinity).

Results and safety

The study was stopped early (reason given: Stopped due to a strategic decision.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Individual participant dataSharing planned: 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

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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-0440 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: stopped early, as of the sponsor's last update on 3 Feb 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 was stopped early (reason given: Stopped due to a strategic 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?

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: Approximately up to 37 days). The study lists 16 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 NCT03915886.

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 3 Feb 2025.