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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03270579 | A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]JNJ-64511070 | PHASE1 | COMPLETED | 8 | — | — | Sep 12, 2017 | Feb 6, 2018 | Apr 27, 2025 | 1 | Belgium |
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...