A Phase 1 interventional study of [11C] JNJ-42491293 and [11C] JNJ-42491293 + JNJ-40411813 in Healthy, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-22.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 1 and Interventional
The purpose of this study is to evaluate [11C] JNJ-42491293 as a PET ligand in healthy adult volunteers.
This is an open-label (volunteers will know the identity of assigned treatment) study in healthy adult volunteers and will consist of 4 consecutive parts, A, B, C, and D. Advancement to parts B, C, and D will occur only if the objectives of the preceding parts are met. Healthy adult volunteers will be recruited for each part of the study. This will be the first study in which 42491293 will be given to healthy adult volunteers. Part A will investigate the measurement of radiation (referred to as radiation dosimetry) of 42491293. Part B will measure the regional brain kinetics (activity) and binding properties of 42491293. Part C will assess the dose dependent blocking of 42491293 by 40411813 in brain tissues following single oral doses of 40411813. Part D will assess the 'duration of occupancy' of the metabotropic glutamate receptor-2 (mGluR2) positive allosteric modulator (PAM) site in the brain by 40411813 compared to peripheral clearance. In this study, 42491293 will be radio-labeled and evaluated as a potential positron emission tomography (PET) ligand for use in imaging studies of the brain to detect binding of 40411813, a compound being developed for treating patients with psychiatric conditions such as schizophrenia and anxiety disorders. In Parts A,B,C, and D, [11C] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection. During Part C and D, JNJ-40411813 (up to 500mg) will be administered orally (by mouth) 1.5 to 3 hours prior to scheduled PET scans.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
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Exclusion Criteria:
\[11C\] JNJ-42491293 + JNJ-40411813 Part C:\[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v.bolus injection. Volunteers will be pre-treated with JNJ-40411813 between 1.5 to 3 hours prior to the second and prior to the third PET scan,\[11C\] JNJ-42491293 + JNJ-40411813 Part D:\[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection. Volunteers will be treated with a single dose of up to 500 mg JNJ-40411813 prior to the second scan and will have a third scan at least 2 hours later to evaluate the rate of clearance of JNJ-40411813 from the brain,\[11C\] JNJ-42491293 Part A: \[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection and have a 120 minute PET scan.,\[11C\] JNJ-42491293 Part B:\[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection have a 90 minute PET scan and have arterial and venous blood sampling.
Drug: [11C] JNJ-42491293 · Drug: [11C] JNJ-42491293 + JNJ-40411813
Part B:\[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection, have a 90 minute PET scan and have arterial and venous blood sampling.
Part C:\[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v.bolus injection. Volunteers will be pre-treated with JNJ-40411813 between 1.5 to 3 hours prior to the second and prior to the third PET scan
Part D:\[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection. Volunteers will be treated with a single dose of up to 500 mg JNJ-40411813 prior to the second scan and will have a third scan at least 2 hours later to evaluate the rate of clearance of JNJ-40411813 from the brain
Part A: \[11C\] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection and have a 120 minute PET scan.
Metabolism (uptake, distribution, and clearance) of [11C] JNJ-42491293 in brain (Part B)
Time frame: Up to approximately 8 days
Adverse events (All Parts)
Time frame: Up to approximately 8 days (Part A); Up approximately 8 days (Part B); Up to 16 days (Part C); Up to approximately 9 days (Part D)
Biodistribution of [11C] JNJ-42491293 (Part A)
Time frame: Up to approximately 8 days
Radiation dosimetry of [11C] JNJ-42491293 (Part A)
Time frame: Up to approximately 8 days
Peripheral metabolism of [11C] JNJ-42491293 (Part B)
Time frame: Up to approximately 8 days
Distribution of [11C] JNJ-42491293 in the brain by pre-treatment with single oral doses of JNJ-40411813 (Part C and Part D)
Time frame: Up to approximately 16 days (Part C); Up to approximately 9 days (Part D)
Clearance rate of JNJ-40411813 from the brain (Part D)
Time frame: Up to approximately 9 days
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.