HealthyPhase 1NCT03864601
A Study of (14C) Radiolabeled JNJ-56136379 in Healthy Male Participants
A Phase 1 study testing 14C-JNJ-56136379 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to investigate the absorption, the metabolic pathways, the route and rate of elimination, and total recovery of 14C-JNJ-56136379 and/or total drug derived radioactivity in healthy male adult participants after administration of a single oral dose of 14C-JNJ-56136379. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 14C-JNJ-56136379
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 14 Jun 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- During the study (from the day of study drug intake onwards) and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving study drug, a male participant: must agree: (a) to wear a condom when engaging in any activity that allows for passage of ejaculate to another person (male participant should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak); (b) not to donate sperm for the purpose of reproduction.
- Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
- Must have a 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 screening
- Healthy on the basis of physical examination, medical history and surgical history, and vital signs 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
- Must have a normal 12-lead electrocardiogram (ECG) at screening
Who cannot join
- Any evidence of heart block or bundle branch block at screening
- Human immunodeficiency virus 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
- History of hepatitis A, B, C, or E infection, or current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E [HEV] antibody IgM [in case HEV IgM positive, a confirmatory HEV ribonuclic acid {RNA} test should be performed]) at screening
- Any current, or history of, confirmed clinically significant skin disease requiring intermittent or chronic treatment such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
- A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-label Study to Determine the Absorption, Metabolism, and Routes of Excretion, Following Oral Administration of (14C) Radiolabeled JNJ-56136379 in Healthy Male Subjects
The purpose of this study is to investigate the absorption, the metabolic pathways, the route and rate of elimination, and total recovery of 14C-JNJ-56136379 and/or total drug derived radioactivity in healthy male adult participants after administration of a single oral dose of 14C-JNJ-56136379.
- Conditions
- Healthy
- Being tested
- 14C-JNJ-56136379
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-JNJ-56136379Drug
14C-JNJ-56136379 25 mg dose formulated as a polyethylene glycol (PEG)-based oral solution containing 3,145 kilo Becquerel (kBq) of 14C labeled JNJ-56136379, with a maximal total radiation burden of 1,000 micro Sievert.
| Study group | Role | What they receive |
|---|---|---|
| 14C-JNJ-56136379 | Experimental | Participants will receive a single oral 25 milligram (mg) dose of 14C-JNJ-56136379 on Day 1 under fed conditions. Receives: Drug: 14C-JNJ-56136379 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma
Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for maximum observed plasma concentration (Cmax) will be assessed.
Measured: Up to 552 hours postdose
AUC(0-last): Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma
Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for area under the plasma concentration-time curve from time zero to last quantifiable concentration time (AUC[0-last]) will be assessed.
Measured: Up to 552 hours postdose
AUC(0-infinity): Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma
Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for area under the plasma concentration- time curve from time zero to infinite time (AUC [0-infinity]) will be assessed.
Measured: Up to 552 hours postdose
Total Radioactivity in Whole Blood, Plasma, Feces and Urine for 14C-JNJ-56136379
The total radioactivity of 14C-JNJ-56136379 in the whole blood plasma, feces and urine will be calculated.
Measured: Up to 552 hours postdose
Total Recovery of Radioactive Dose in Feces and Urine for 14C-JNJ-56136379
The amount of 14C-JNJ-56136379 recovered from the total administered radioactive dose in the feces and urine will be calculated.
Measured: Up to 552 hours postdose
Secondary outcomes (15)
Metabolic Profiles of JNJ-56136379 in Plasma, Urine, and Feces
The metabolite profiling of JNJ-56136379 in different matrices like plasma, urine, and feces will be performed and reported.
Measured: Predose (Day 1), 1, 2, 4, 8, 24, 48, 96, 192, 288, 432, 552 hours postdose (Day 24)
Maximum Observed Plasma Concentration (Cmax) of JNJ-56136379
Cmax is defined as the maximum observed plasma concentration.
Measured: Predose (Day 1), 1, 2, 4, 8, 24, 48, 96, 192, 288, 432, 552 hours postdose (Day 24)
Actual Sampling Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Measured: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0- Last]) of JNJ-56136379
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: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-56136379
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: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Percentage of AUC(0-inifinity) (%AUC[0- infinity],ex of JNJ-56136379
%AUC(0-infinity).ex is the percentage of AUC obtained by extrapolation, calculated by the following equation: (AUC[0-inifinity] - AUC[0-last])/AUC(0-inifinity)*100.
Measured: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Apparent Terminal Elimination Half-Life (t1/2) of JNJ-56136379
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 drug concentration time curve, and is calculated as 0.693/lambda(z).
Measured: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Apparent Terminal Elimination Rate Constant (Lambda[z]) of JNJ-56136379
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: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Amount of JNJ-56136379 Excreted in Urine within the Time Interval t1 to t2 (Ae[t1-t2])
Ae(t1-t2) is the amount of JNJ-56136379 excreted into urine for the collection interval from t1 to t2, where t1 and t2 are the start and end times of the interval, respectively, calculated by multiplying the urinary volume with the urinary concentration for that interval.
Measured: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Amount of JNJ-56136379 Excreted in Urine (Ae)
The Ae is the amount of JNJ-56136379 excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.
Measured: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Percentage of JNJ-56136379 Excreted in Urine (Ae%dose)
The Ae%dose is the percentage of JNJ-56136379 dose excreted into the urine calculated as (Ae/dose)∗100.
Measured: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Amount of JNJ-56136379 Excreted in Feces within the Time Interval t1 to t2 (Fe[t1-t2])
The Fe(t1-t2) is the amount of JNJ-56136379 excreted into feces for the collection interval from t1 to t2, where t1 and t2 are the start and end times of the interval, respectively, calculated by multiplying the fecal volume with the fecal concentration for that interval.
Measured: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Amount of JNJ-56136379 Excreted in Feces (Fe)
The Fe is the amount of JNJ-56136379 excreted in feces. It is calculated by multiplying the fecal volume with the fecal drug concentration.
Measured: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Percentage of JNJ-56136379 Excreted in Feces (Fe,%dose)
The Fe%dose is the percentage of JNJ-56136379 dose excreted into the feces calculated as (Fe/dose)*100.
Measured: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
Measured: Approximately up to 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start9 Apr 2019
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
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.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864601
- Sponsor's protocol ID
- CR108586
- Other IDs
- 56136379HPB1007
- Status last verified
- Jan 2025
- First submitted
- 5 Mar 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
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 Phase 1, Open-label Study to Determine the Absorption, Metabolism, and Routes of Excretion, Following Oral Administration of (14C) Radiolabeled JNJ-56136379 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03864601
- Acronym / sponsor ID
- CR108586
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 6 Mar 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.
The purpose of this study is to investigate the absorption, the metabolic pathways, the route and rate of elimination, and total recovery of 14C-JNJ-56136379 and/or total drug derived radioactivity in healthy male adult participants after administration of a single oral dose of 14C-JNJ-56136379.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-JNJ-56136379 | Experimental | Drug: 14C-JNJ-56136379Participants will receive a single oral 25 milligram (mg) dose of 14C-JNJ-56136379 on Day 1 under fed conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- During the study (from the day of study drug intake onwards) and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving study drug, a male participant: must agree: (a) to wear a condom when engaging in any activity that allows for passage of ejaculate to another person (male participant should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak); (b) not to donate sperm for the purpose of reproduction.
- Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
- Must have a 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 screening
- Healthy on the basis of physical examination, medical history and surgical history, and vital signs 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
Key exclusion criteria (5 listed)
- Any evidence of heart block or bundle branch block at screening
- Human immunodeficiency virus 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
- History of hepatitis A, B, C, or E infection, or current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E [HEV] antibody IgM [in case HEV IgM positive, a confirmatory HEV ribonuclic acid {RNA} test should be performed]) at screening
- Any current, or history of, confirmed clinically significant skin disease requiring intermittent or chronic treatment such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
- A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
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 |
|---|---|---|
| 14C-JNJ-5613637914C-JNJ-56136379 25 mg dose formulated as a polyethylene glycol (PEG)-based oral solution containing 3,145 kilo Becquerel (kBq) of 14C labeled JNJ-56136379, with a maximal total radiation burden of 1,000 micro Sievert. | Drug | 14C-JNJ-56136379 |
Primary outcome
Cmax: Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma
Time frame: Up to 552 hours postdose
Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for maximum observed plasma concentration (Cmax) will be assessed.
AUC(0-last): Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma
Time frame: Up to 552 hours postdose
Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for area under the plasma concentration-time curve from time zero to last quantifiable concentration time (AUC[0-last]) will be assessed.
AUC(0-infinity): Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma
Time frame: Up to 552 hours postdose
Ratio of JNJ-56136379 concentration (plasma) and total radioactivity (plasma) for area under the plasma concentration- time curve from time zero to infinite time (AUC [0-infinity]) will be assessed.
Total Radioactivity in Whole Blood, Plasma, Feces and Urine for 14C-JNJ-56136379
Time frame: Up to 552 hours postdose
The total radioactivity of 14C-JNJ-56136379 in the whole blood plasma, feces and urine will be calculated.
Total Recovery of Radioactive Dose in Feces and Urine for 14C-JNJ-56136379
Time frame: Up to 552 hours postdose
The amount of 14C-JNJ-56136379 recovered from the total administered radioactive dose in the feces and urine will be calculated.
15 secondary outcomes
Metabolic Profiles of JNJ-56136379 in Plasma, Urine, and Feces
Time frame: Predose (Day 1), 1, 2, 4, 8, 24, 48, 96, 192, 288, 432, 552 hours postdose (Day 24)
Maximum Observed Plasma Concentration (Cmax) of JNJ-56136379
Time frame: Predose (Day 1), 1, 2, 4, 8, 24, 48, 96, 192, 288, 432, 552 hours postdose (Day 24)
Actual Sampling Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379
Time frame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration Time (AUC [0- Last]) of JNJ-56136379
Time frame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-56136379
Time frame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Percentage of AUC(0-inifinity) (%AUC[0- infinity],ex of JNJ-56136379
Time frame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Apparent Terminal Elimination Half-Life (t1/2) of JNJ-56136379
Time frame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Apparent Terminal Elimination Rate Constant (Lambda[z]) of JNJ-56136379
Time frame: Predose (Day 1), 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, 96, 192, 288, 432, 552 hours postdose (Day 24)
Amount of JNJ-56136379 Excreted in Urine within the Time Interval t1 to t2 (Ae[t1-t2])
Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Amount of JNJ-56136379 Excreted in Urine (Ae)
Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Percentage of JNJ-56136379 Excreted in Urine (Ae%dose)
Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Amount of JNJ-56136379 Excreted in Feces within the Time Interval t1 to t2 (Fe[t1-t2])
Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Amount of JNJ-56136379 Excreted in Feces (Fe)
Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Percentage of JNJ-56136379 Excreted in Feces (Fe,%dose)
Time frame: Predose and at every 24-hour interval up to 552 hours (Day 24) postdose
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Approximately up to 2.5 months
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 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
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 14C-JNJ-56136379 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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 6 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 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 United States. 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?
Cmax: Ratio of JNJ-56136379 Concentration and Total Radioactivity in Plasma (time frame: Up to 552 hours postdose). 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?
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.