Invicro
New Haven, Connecticut, 06510, United States
NCT Number: NCT03581916
The purpose of this study is to measure the whole-body distribution and radiation dosimetry of 18F-JNJ-64326067 in healthy participants.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
New Haven, Connecticut, 06510, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(a) who is sexually active with a woman of childbearing potential and has not had vasectomy must agree to use a barrier method of contraception (that is, condom). In addition, their female partner should also use a highly effective method of birth control (example, hormonal contraception) for at least the same duration, (b) who is sexually active with a woman who is pregnant must use a condom, (c) must agree not to donate sperm
Exclusion criteria
18F-JNJ-64326067 will be administered intravenously between a dose of 185 Megabecquerel (MBq) to 370 MBq.
Time frame: Day 1
The Effective Dose (ED) per organ will be calculated using Organ Level Internal Dose Assessment (OLINDA) software. After injection of 370 megaBecquerel (MBq) of 18F-JNJ-64326067, a series of whole-body positron emission tomography (PET) images will be obtained over a period of up to 6 hours and corrected for attenuation by computed tomography (CT) transmission scans using PET/CT. The unit of radioactivity will be milli Sieverts per mega Becquerel (mSv/MBq) for each organ and the effective dose per participant. The final values will be averaged across the participants.
Time frame: Day 1
The ED for whole body will be calculated using OLINDA software. After injection of 370 MBq of 18F-JNJ-64326067, a series of whole-body PET images will be obtained over a period of up to 6 hours and corrected for attenuation by CT transmission scans using PET/CT. The unit of radioactivity will be mSv/MBq for the whole body and the effective dose per participant. The final values will be averaged across the participants.
Time frame: Up to 36 days
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 Total Body Distribution and Radiation Dosimetry of the Positron Emission Tomography Ligand 18F-JNJ-64326067 in Healthy Subjects
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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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