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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 being developed by Johnson & Johnson (JNJ). It is a positron emission tomography (PET) ligand, studied in a Phase 1 clinical trial in healthy male volunteers. The drug is not approved and remains in clinical development.
JNJ-64511070 is being studied for use as a PET imaging ligand to investigate regional brain kinetics. It is intended for use in healthy volunteers to assess brain distribution, though its specific diagnostic or therapeutic indication has not been established.
JNJ-64511070 is developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 clinical trial of this investigational small molecule.
JNJ-64511070 is in Phase 1 clinical development. A single Phase 1 study has been completed, involving 8 healthy male participants in Belgium. The drug is investigational and has not received FDA approval.
JNJ-64511070 has one completed Phase 1 trial, NCT03270579, titled 'A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]JNJ-64511070.' The trial enrolled 8 healthy male volunteers aged 18 years and older in Belgium.
Yes, JNJ-64511070 is the same as [18F]JNJ-64511070. The [18F] designation indicates the compound is labeled with the radioactive isotope fluorine-18 for use in positron emission tomography (PET) imaging, as described in the clinical trial NCT03270579.