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

NCT03270579 | Completed Phase 1

• 3 other identifiers: CR1083792017-002262-4764140284EDI1002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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 by PET and to model tissue specific kinetics of \[18F\]JNJ-64511070 with the appropriate arterial input function (IF) (Part B).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 5 hours on Day 1

• 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.

  Day 1

Secondary Outcomes (1)

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

  Approximately Up to 4 weeks

Study Arms (2)

Part A: [18F]JNJ-64511070

EXPERIMENTAL

Participants 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.

Drug: [18F]JNJ-64511070

Part B: [18F]JNJ-64511070

EXPERIMENTAL

Participants 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.

Drug: [18F]JNJ-64511070

Interventions

[18F]JNJ-64511070 DRUG

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

Part A: [18F]JNJ-64511070; Part B: [18F]JNJ-64511070

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 40694102 DERIVED

Study Officials

• Janssen Research & Development, LLC. Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 1, 2017
• Study Start: September 12, 2017
• Primary Completion: February 6, 2018
• Study Completion: February 6, 2018
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

BE (1)