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Also known as [18F]JNJ-64511070
JNJ-64511070 · 1 trial · 1 indication
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| [18F]JNJ-64511070 | DRUG | An IV injection of 185 MBq \[18F\]JNJ-64511070 will be administered. |
Inclusion Criteria: * 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 (A...
JNJ-64511070 is an investigational small molecule developed by Johnson & Johnson, also known as [18F]JNJ-64511070. It is a fluorine-18 labeled positron emission tomography ligand studied for imaging regional brain kinetics. It is not a therapeutic treatment; it is a research imaging agent evaluated in healthy male volunteers.
JNJ-64511070 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The compound is also referred to as [18F]JNJ-64511070, reflecting its fluorine-18 radiolabel used for positron emission tomography imaging.
JNJ-64511070 is in Phase 1 development. It has been evaluated in a single completed Phase 1 study, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA for any use.
JNJ-64511070 was studied in NCT03270579, titled A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]JNJ-64511070. The Phase 1 trial enrolled 8 healthy male volunteers aged 18 years and older in Belgium and is completed.
Yes, [18F]JNJ-64511070 is another name for JNJ-64511070. The bracketed fluorine-18 notation indicates the radiolabeled form of the compound used as a positron emission tomography ligand, so both names refer to the same Johnson & Johnson imaging agent.