HealthyPhase 1NCT01359852
A Study of [11C]JNJ-42491293, a Possible PET Ligand for the mGlu2 Receptor, in Healthy Adult Volunteers
A Phase 1 study testing [11C] JNJ-42491293 and [11C] JNJ-42491293 + JNJ-40411813 in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate [11C] JNJ-42491293 as a PET ligand in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [11C] JNJ-42491293 and [11C] JNJ-42491293 + JNJ-40411813
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
About this study
Official title: 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
The purpose of this study is to evaluate [11C] JNJ-42491293 as a PET ligand in healthy adult volunteers.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- [11C] JNJ-42491293, [11C] JNJ-42491293 + JNJ-40411813
- Keywords
- JNJ-42491293, JNJ-40411813, Metabotropic glutamate subtype 2 receptor (mGlu2R), Positive allosteric modulator (PAM), positron emission tomography (PET)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C] JNJ-42491293Drug
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.
[11C] JNJ-42491293 + JNJ-40411813Drug
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-40411813Drug
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-42491293Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | [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. Receives: Drug: [11C] JNJ-42491293; Drug: [11C] JNJ-42491293 + JNJ-40411813 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolism (uptake, distribution, and clearance) of [11C] JNJ-42491293 in brain (Part B)
Measured: Up to approximately 8 days
Adverse events (All Parts)
Measured: 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)
Measured: Up to approximately 8 days
Radiation dosimetry of [11C] JNJ-42491293 (Part A)
Measured: Up to approximately 8 days
Peripheral metabolism of [11C] JNJ-42491293 (Part B)
Measured: Up to approximately 8 days
Secondary outcomes (2)
Distribution of [11C] JNJ-42491293 in the brain by pre-treatment with single oral doses of JNJ-40411813 (Part C and Part D)
Measured: Up to approximately 16 days (Part C); Up to approximately 9 days (Part D)
Clearance rate of JNJ-40411813 from the brain (Part D)
Measured: Up to approximately 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startDec 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359852
- Sponsor's protocol ID
- CR017848
- Other IDs
- 42491293EDI1001, 2010-022063-36
- Status last verified
- Jul 2011
- First submitted
- 12 May 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01359852
- Acronym / sponsor ID
- CR017848
- Conditions
- Healthy
- Keywords
- JNJ-42491293, JNJ-40411813, Metabotropic glutamate subtype 2 receptor (mGlu2R), Positive allosteric modulator (PAM), positron emission tomography (PET)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate [11C] JNJ-42491293 as a PET ligand in healthy adult volunteers.
Detailed description
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: [11C] JNJ-42491293, Drug: [11C] JNJ-42491293 + JNJ-40411813[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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C] JNJ-42491293Part 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 | 001 |
| [11C] JNJ-42491293 + JNJ-40411813Part 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 | Drug | 001 |
| [11C] JNJ-42491293 + JNJ-40411813Part 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 | Drug | 001 |
| [11C] JNJ-42491293Part A: [11C] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection and have a 120 minute PET scan. | Drug | 001 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [11C] JNJ-42491293 and [11C] JNJ-42491293 + JNJ-40411813 in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolism (uptake, distribution, and clearance) of [11C] JNJ-42491293 in brain (Part B) (time frame: Up to approximately 8 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.