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JNJ-70099731 · 1 trial · 1 indication
Normalized cumulative activity and residence time will be reported.
The tissue radioactivity will be measured per organ for up to 5 hours after injection of \[18F\]-JNJ-70099731 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-70099731 in brain will be measured by PET/CT scans obtained from the time of injection 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.
Participant variability in PET distribution parameters over time will be compared between the paired PET scans to assess test-retest variability in the regional brain kinetics and binding properties of \[18F\]-JNJ-70099731.
| Arm | Type | Description |
|---|---|---|
| Part A: [18F]-JNJ-70099731 | EXPERIMENTAL | Participants will receive an intravenous (IV) bolus injection of \[18F\]-JNJ-70099731 on Day 1 of Part A to investigate the total body bio-distribution and measure the radiation dosimetry of \[18F\]-JNJ-70099731. |
| Part B: [18F]-JNJ-70099731 | EXPERIMENTAL | Participants will receive an IV bolus injection of \[18F\]-JNJ-70099731 on Day 1 of Part B to measure the uptake, distribution, and clearance of \[18F\]-JNJ-70099731 and to model the tissue specific kinetics of \[18F\]-JNJ-70099731 in the human brain with the appropriate arterial input function. |
| Part C: [18F]-JNJ-70099731 | EXPERIMENTAL | Participants will receive an IV bolus injection of \[18F\]-JNJ-70099731 on Day 1 of each period of Part C to determine the test-retest variability in the regional brain kinetics and binding properties of \[18F\]-JNJ-70099731. |
| Name | Type | Description |
|---|---|---|
| [18F]-JNJ-70099731 | DRUG | \[18F\]JNJ-70099731 injection will be administered intravenously. |
Inclusion Criteria: * Body mass index (BMI) between 18 and 32 kilogram per meter square (kg/m\^2) inclusive * Participant must be healthy on the basis of physical and neurological examination, medical history, clinical laboratory tests, vital sign (VS), and 12-lead electrocardiogram (ECG) performed...
JNJ-70099731 is an investigational small molecule being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers as part of a positron emission tomography (PET) ligand study to investigate its regional brain kinetics.
JNJ-70099731 is being studied for use in healthy participants. The completed Phase 1 trial, NCT04911543, investigated the regional brain kinetics of the PET ligand [18F]-JNJ-70099731 in healthy male participants. The drug is not approved for any indication and remains in clinical development.
JNJ-70099731 is developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational small molecule currently in Phase 1 clinical trials.
JNJ-70099731 is in Phase 1 clinical development. The only trial for this drug, NCT04911543, has been completed. The drug is investigational and has not been approved by regulatory authorities.
JNJ-70099731 has one completed clinical trial, NCT04911543, titled "A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]-JNJ-70099731 in Healthy Male Participants." The trial enrolled 13 healthy male participants in Belgium and was a controlled, non-randomized, open-label study.