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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002262-47 | EudraCT Number | ||
| 64140284EDI1002 | Other Identifier | Janssen Research & Development, LLC |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]JNJ-64511070 | Drug | An IV injection of 185 MBq [18F]JNJ-64511070 will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately Up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC. Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40694102 | Derived | 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. |
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