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HealthyPhase 1NCT03270579

A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]JNJ-64511070

A Phase 1 study testing [18F]JNJ-64511070 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 main purpose of the study is to measure the whole-body distribution and radiation dosimetry of [18F]JNJ-64511070 in healthy male participants by positron emission tomography (PET) (Part A); and to measure the uptake, binding, distribution, and washout of [18F]JNJ-64511070 in the brain of healthy male participants… 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-64511070
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteBelgium
Study dates
12 Sep 2017to 6 Feb 2018
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 30 kilogram per meter square (kg/m^2) inclusive
  • Nonsmoker (not smoked for 3 months prior to screening)
  • Is willing to allow the investigators to place an arterial catheter in the radial artery and is assessed via physical examination (Allen test) to be a good candidate for arterial catheter placement (Part B only)
  • During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, a man: a) who is sexually active with a woman of childbearing potential and has not had vasectomy must agree to use a condom and their female partner should also use a highly effective method of birth control for at least the same duration; b) who is sexually active with a woman who is pregnant must use a condom; c) must agree not to donate sperm
  • Participants must have signed an informed consent document indicating that they understand the purpose of, and procedures required for,the study and are willing to participate in the study and comply with the study procedures and restrictions

Who cannot join

  • Exposed to greater than (>) 1 milliSievert (mSv) of ionizing radiation participating as a participant in research studies in the 12 months before the start of enrolment in this study
  • Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission. 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 both the investigator are acceptable
  • Clinically significant abnormal physical and neurological examination, vital signs or 12-lead electrocardiogram (ECG) at screening or admission
  • 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 fits or unexplained black-outs or loss of consciousness should also be excluded
  • Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibodies or human immunodeficiency (HIV) antibodies unless the participant has been successfully treated for HCV or HIV. In such cases, the response should be confirmed with RNA testing for the relevant pathogen

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-64511070

The main purpose of the study is to measure the whole-body distribution and radiation dosimetry of [18F]JNJ-64511070 in healthy male participants by positron emission tomography (PET) (Part A); and to measure the uptake, binding, distribution, and washout of [18F]JNJ-64511070 in the brain of healthy male participants by PET and to model tissue specific kinetics of [18F]JNJ-64511070 with the appropriate arterial input function (IF) (Part B).

Conditions
Healthy
Being tested
[18F]JNJ-64511070

What participants receive

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

  • [18F]JNJ-64511070Drug

    An IV injection of 185 MBq [18F]JNJ-64511070 will be administered.

Study groups in NCT03270579
Study groupRoleWhat they receive
Part A: [18F]JNJ-64511070ExperimentalParticipants will receive an intravenous (IV) bolus injection of [18F]JNJ-64511070 at a dose of 185 megaBecquerel (MBq) on Day 1 of Part A to investigate the total body biodistribution and measure the radiation dosimetry of [18F]JNJ-64511070.
Receives: Drug: [18F]JNJ-64511070
Part B: [18F]JNJ-64511070ExperimentalParticipants will receive an IV bolus injection of [18F]JNJ-64511070 at a dose of 185 MBq on Day 1 of Part B to measure the uptake, binding, distribution, and washout of [18F]JNJ-64511070 and to model the tissue specific kinetics of [18F]JNJ-64511070 in the human brain with the appropriate arterial IF.
Receives: Drug: [18F]JNJ-64511070

What is being measured

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

  1. Part A: Effective Radiation Dose Following Injection of [18F]JNJ-64511070

    The tissue radioactivity will be measured per organ for up to 5 hours after injection of up to 185 megaBecquerel (MBq) of [18F]JNJ-64511070 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: Up to 5 hours on Day 1

  2. Part B: Total and Regional Brain Compartmental Kinetics for Volume of Distribution of [18F]JNJ-64511070 in Brain

    The Distribution of [18F]JNJ-64511070 in brain will be measured by PET/CT scans obtained from the time of injection for up to 120 minutes 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 (V[t]) of [18F]JNJ-64511070.

    Measured: Day 1

Secondary outcomes (1)

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measured: Approximately Up to 4 weeks

Timeline

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

  1. First posted1 Sep 2017
  2. Study start12 Sep 2017
  3. Primary completion6 Feb 2018
  4. Study completion6 Feb 2018

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
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03270579
Sponsor's protocol ID
CR108379
Other IDs
2017-002262-47, 64140284EDI1002, 2017
Status last verified
Apr 2025
First submitted
31 Aug 2017
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Koole M, Schmidt ME, Hijzen A, Cohilis M, Vandermeulen C, Serdons K, Celen S, Bormans G, Maher M, Szardenings AK, Zhang W, Kolb H, de Hoon J, Van Laere K. Dosimetry and kinetic modelling of [18F]JNJ-64511070, a novel PET ligand to quantify AMPA-associated TARP-gamma8 receptors in the human brain. Eur J Nucl Med Mol Imaging. 2025 Dec;53(1):491-504. doi: 10.1007/s00259-025-07428-3. Epub 2025 Jul 22.

    PubMed 40694102

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]JNJ-64511070 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: Effective Radiation Dose Following Injection of [18F]JNJ-64511070 (time frame: Up to 5 hours on Day 1). The study lists 2 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 NCT03270579, which also lists 1 linked publication.

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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