UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
NCT Number: NCT03270579
The main purpose of the study is to measure the whole-body distribution and radiation dosimetry of [18F]JNJ-64511070 in healthy male participants by positron emission tomography (PET) (Part A); and to measure the uptake, binding, distribution, and washout of [18F]JNJ-64511070 in the brain of healthy male participants by PET and to model tissue specific kinetics of [18F]JNJ-64511070 with the appropriate arterial input function (IF) (Part B).
Looking for future studies?
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
An IV injection of 185 MBq [18F]JNJ-64511070 will be administered.
Time frame: Up to 5 hours on Day 1
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.
Time frame: Day 1
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.
Time frame: Approximately Up to 4 weeks
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Janssen Research & Development, LLC
Industry
An Open-Label Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]JNJ-64511070
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT06702423
Healthy
London, United Kingdom
View Trial DetailsNCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details