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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000675-36 | EudraCT Number | ||
| 69095897EDI1003 | Other Identifier | Janssen Research & Development, LLC |
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The purposes of this study are to measure the whole-body distribution and radiation dosimetry of [18F]-JNJ-70099731 (Part A), to measure the uptake, distribution, and clearance (CL) of [18F]-JNJ-70099731 by Positron Emission Tomography (PET) and to model tissue specific kinetics of [18F]-JNJ-70099731 with the appropriate input function (IF) (Part B), and to measure participant test-retest variability in the distribution of [18F]-JNJ-70099731 by comparing PET scans obtained at least 1 week apart (Part C) in the brain of healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]-JNJ-70099731 | Drug | [18F]JNJ-70099731 injection will be administered intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A: Normalized Cumulative Activity and Residence Time | Normalized cumulative activity and residence time will be reported. | Day 1 |
| Part A: Radiation Absorbed Doses for 25 Organs and the Effective Dose (ED) of [18F]-JNJ-70099731 | 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. | Day 1 |
| Part B: Input Function Values kilobecquerel (kBq/cc) for Various Time Points and Tracer Kinetics in Selected Brain Structures | 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. | Day 1 |
| Part C: Participant Variability in PET Distribution Parameters Over Time | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A, B and C: Number of Participants with Adverse Events as a Measure of Safety and Tolerability | An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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| Part A and B: Up to Week 5; Part C: Up to Week 6 |
| Part A, B and C: Number of Participants with Change from Baseline in Treatment Emergent Vital Signs Abnormalities | Number of participants with change from baseline in treatment emergent vital signs (Pulse Rate [PR], Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) will be assessed. | Part A and B: Baseline, up to Week 5, Part C: Baseline, up to Week 6 |
| Part A, B and C: Number of Participants with Change from Baseline in Treatment Emergent Clinical Labs (Chemistry, Hematology, Urinalysis) Abnormalities | Number of participants with change from baseline in treatment emergent clinical labs (Chemistry, Hematology, Urinalysis) will be assessed. | Part A and B: Baseline, up to Week 5, Part C: Baseline, up to Week 6 |
| Part A, B and C: Number of Participants with Change from Baseline in Treatment Emergent Electrocardiogram (ECG) Abnormalities | Number of participants with change from baseline in Heart Rate (HR), Respiratory Rate (RR), QRs Interval, QTc Interval and PR Interval will be measured by ECG. | Part A and B: Baseline, up to Week 5; Part C: Baseline, up to Week 6 |