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HealthyPhase 1NCT04911543

A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]-JNJ-70099731 in Healthy Male Participants

A Phase 1 study testing [18F]-JNJ-70099731 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purposes of this study are to measure the whole-body distribution and radiation dosimetry of [18F]-JNJ-70099731 (Part A), to measure the uptake, distribution, and clearance (CL) of [18F]-JNJ-70099731 by Positron Emission Tomography (PET) and to model tissue specific kinetics of [18F]-JNJ-70099731 with the… 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?
[18F]-JNJ-70099731
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteBelgium
Study dates
23 Jun 2021to 1 Feb 2022
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

  • Body mass index (BMI) between 18 and 32 kilogram per meter square (kg/m^2) inclusive
  • Participant must be healthy on the basis of physical and neurological examination, medical history, clinical laboratory tests, vital sign (VS), and 12-lead electrocardiogram (ECG) performed at screening. Minor deviations in ECG (example, first-degree atrioventricular block), which are not considered to be of clinical significance to the investigator, are acceptable
  • Participant must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study
  • Part B \& Part C only: Participant is willing to allow the investigators to place an arterial catheter in the radial artery. Suitability for arterial catheter placement will be assessed via physical examination (modified Allen Test on both hands). Participant should not be allergic to local anesthetics for catheter placement
  • Participant must agree not to donate sperm during the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention. If a participant is sexually active with a woman, he should agree to the following: a) If it concerns a woman of childbearing potential and the participant has not had a vasectomy, the participant must agree to use a condom and make sure his female partner is using a highly effective method of birth control during the study and for a minimum of 90 days after the last dose of study intervention; b) If it concerns a woman of nonchild bearing potential or who is pregnant or has been sterilized and the participant has not had a vasectomy, the participant must agree to use a condom for the given period; c) If the participant has had a vasectomy, he should agree to use a condom when being sexually active with a woman of childbearing potential. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

Who cannot join

  • Clinically significant abnormal values for hematology, clinical chemistry, coagulation or urinalysis at screening. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the Principal Investigator, are acceptable
  • Clinically significant abnormal physical and neurological examination, VS or 12-lead ECG at screening or before study intervention administration
  • History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, coagulation abnormalities, or other conditions that the Investigator considers should exclude the participant and preclude their ability to participate in study procedures. Participants with a history significant liver or renal disease, or difficulty in urination, which could affect the metabolism and elimination of the radiotracer or radiometabolites should be excluded. Participants with a history of epilepsy or seizures of significance or unexplained black-outs or loss of consciousness should also be excluded
  • Exposed to greater than (>)1 millisievert (mSv) of ionizing radiation participating as a participant in research studies and/or at work in the 12 months before the start of this study, to the participant's knowledge
  • Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

About this study

Official title: An Open-Label Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]-JNJ-70099731 in Healthy Male Participants

The purposes of this study are to measure the whole-body distribution and radiation dosimetry of [18F]-JNJ-70099731 (Part A), to measure the uptake, distribution, and clearance (CL) of [18F]-JNJ-70099731 by Positron Emission Tomography (PET) and to model tissue specific kinetics of [18F]-JNJ-70099731 with the appropriate input function (IF) (Part B), and to measure participant test-retest variability in the distribution of [18F]-JNJ-70099731 by comparing PET scans obtained at least 1 week apart (Part C) in the brain of healthy male participants.

Conditions
Healthy
Being tested
[18F]-JNJ-70099731

What participants receive

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

  • [18F]-JNJ-70099731Drug

    [18F]JNJ-70099731 injection will be administered intravenously.

Study groups in NCT04911543
Study groupRoleWhat they receive
Part A: [18F]-JNJ-70099731ExperimentalParticipants will receive an intravenous (IV) bolus injection of [18F]-JNJ-70099731 on Day 1 of Part A to investigate the total body bio-distribution and measure the radiation dosimetry of [18F]-JNJ-70099731.
Receives: Drug: [18F]-JNJ-70099731
Part B: [18F]-JNJ-70099731ExperimentalParticipants will receive an IV bolus injection of [18F]-JNJ-70099731 on Day 1 of Part B to measure the uptake, distribution, and clearance of [18F]-JNJ-70099731 and to model the tissue specific kinetics of [18F]-JNJ-70099731 in the human brain with the appropriate arterial input function.
Receives: Drug: [18F]-JNJ-70099731
Part C: [18F]-JNJ-70099731ExperimentalParticipants will receive an IV bolus injection of [18F]-JNJ-70099731 on Day 1 of each period of Part C to determine the test-retest variability in the regional brain kinetics and binding properties of [18F]-JNJ-70099731.
Receives: Drug: [18F]-JNJ-70099731

What is being measured

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

  1. Part A: Normalized Cumulative Activity and Residence Time

    Normalized cumulative activity and residence time will be reported.

    Measured: Day 1

  2. Part A: Radiation Absorbed Doses for 25 Organs and the Effective Dose (ED) of [18F]-JNJ-70099731

    The tissue radioactivity will be measured per organ for up to 5 hours after injection of [18F]-JNJ-70099731 and corrected for attenuation by computed tomography (CT) transmission scans using positron emission tomography (PET)/CT. These measurements will be used to estimate effective radiation dose per organ and total body.

    Measured: Day 1

  3. Part B: Input Function Values kilobecquerel (kBq/cc) for Various Time Points and Tracer Kinetics in Selected Brain Structures

    The Distribution of [18F]JNJ-70099731 in brain will be measured by PET/CT scans obtained from the time of injection along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics and volume of distribution.

    Measured: Day 1

  4. Part C: Participant Variability in PET Distribution Parameters Over Time

    Participant variability in PET distribution parameters over time will be compared between the paired PET scans to assess test-retest variability in the regional brain kinetics and binding properties of [18F]-JNJ-70099731.

    Measured: Day 1

Secondary outcomes (4)

  1. Part A, B and C: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    An AE 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: Part A and B: Up to Week 5; Part C: Up to Week 6

  2. Part A, B and C: Number of Participants with Change from Baseline in Treatment Emergent Vital Signs Abnormalities

    Number of participants with change from baseline in treatment emergent vital signs (Pulse Rate [PR], Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) will be assessed.

    Measured: Part A and B: Baseline, up to Week 5, Part C: Baseline, up to Week 6

  3. Part A, B and C: Number of Participants with Change from Baseline in Treatment Emergent Clinical Labs (Chemistry, Hematology, Urinalysis) Abnormalities

    Number of participants with change from baseline in treatment emergent clinical labs (Chemistry, Hematology, Urinalysis) will be assessed.

    Measured: Part A and B: Baseline, up to Week 5, Part C: Baseline, up to Week 6

  4. Part A, B and C: Number of Participants with Change from Baseline in Treatment Emergent Electrocardiogram (ECG) Abnormalities

    Number of participants with change from baseline in Heart Rate (HR), Respiratory Rate (RR), QRs Interval, QTc Interval and PR Interval will be measured by ECG.

    Measured: Part A and B: Baseline, up to Week 5; Part C: Baseline, up to Week 6

Timeline

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

  1. First posted3 Jun 2021
  2. Study start23 Jun 2021
  3. Primary completion1 Feb 2022
  4. Study completion1 Feb 2022

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
Basic science
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04911543
Sponsor's protocol ID
CR108996
Other IDs
2021-000675-36, 69095897EDI1003
Status last verified
Apr 2025
First submitted
31 May 2021
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 [18F]-JNJ-70099731 in people with Healthy, run by Janssen Research & Development, LLC 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: finished, 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 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?

Part A: Normalized Cumulative Activity and Residence Time (time frame: Day 1). 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?

On the ClinicalTrials.gov record for NCT04911543.

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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