- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01359852
A Study of [11C]JNJ-42491293, a Possible PET Ligand for the mGlu2 Receptor, in Healthy Adult Volunteers
An Open-Label Study to Investigate the Dosimetry of the Positron Emission Tomography Ligand for the Metabotropic Glutamate Receptor-2 (mGlu2R), [11C]JNJ-42491293, and Displacement by the mGlu2R Positive Allosteric Modulator JNJ-40411813 in Healthy Male Subjects
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive (BMI = weight/height2)
- Nonsmokers (at least 3 months before screening)
- Healthy on the basis of results from physical examination, vital signs, and 12-lead ECG, clinical laboratory tests performed at screening as determined by the Investigator (study physician)
- Willing to adhere to the prohibitions and restrictions specified in this protocol
- Healthy volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
- History of or current medical illness that the Investigator considers to be clinically significant
- History of or current psychiatric or neurological illness including claustrophobia (an abnormal fear of being in narrow or enclosed spaces)
- Exposed to > 1 mSv of ionizing radiation participating as a volunteer in research studies in the year before the start of this study
- Any clinically significant Magnetic Resonance Imaging (MRI) abnormalities at screening, as determined by a neuroradiologist, which are relevant for the study (not applicable for part A)
- Metal implants (pacemakers, joint replacements, etc.) or metal splinters or heavy tattoos, which are relevant for MRI (not applicable for Part A).
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
[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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Metabolism (uptake, distribution, and clearance) of [11C] JNJ-42491293 in brain (Part B)
Time Frame: Up to approximately 8 days
|
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)
|
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
|
Up to approximately 8 days
|
Radiation dosimetry of [11C] JNJ-42491293 (Part A)
Time Frame: Up to approximately 8 days
|
Up to approximately 8 days
|
Peripheral metabolism of [11C] JNJ-42491293 (Part B)
Time Frame: Up to approximately 8 days
|
Up to approximately 8 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
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
|
Up to approximately 9 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR017848
- 42491293EDI1001
- 2010-022063-36
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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