UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
NCT Number: NCT04911543
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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Notify Me18 year–55 year
Male
Interventional
Phase 1
Leuven, 3000, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
[18F]JNJ-70099731 injection will be administered intravenously.
Time frame: Day 1
Normalized cumulative activity and residence time will be reported.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: Part A and B: Up to Week 5; Part C: Up to Week 6
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.
Time frame: Part A and B: Baseline, up to Week 5, Part C: Baseline, up to Week 6
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.
Time frame: Part A and B: Baseline, up to Week 5, Part C: Baseline, up to Week 6
Number of participants with change from baseline in treatment emergent clinical labs (Chemistry, Hematology, Urinalysis) will be assessed.
Time frame: Part A and B: Baseline, up to Week 5; Part C: Baseline, up to Week 6
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.
Janssen Research & Development, LLC
Industry
An Open-Label Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]-JNJ-70099731 in Healthy Male Participants
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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