Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04911543 | A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]-JNJ-70099731 in Healthy Male Participants | PHASE1 | COMPLETED | 13 | — | — | Jun 23, 2021 | Feb 1, 2022 | Apr 27, 2025 | 1 | Belgium |
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...