A Study of [11C]JNJ-42491293, a Possible PET Ligand for the mGlu2 Receptor, in Healthy Adult Volunteers

NCT01359852 | Completed Phase 1

• 3 other identifiers: CR01784842491293EDI10012010-022063-36
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate \[11C\] JNJ-42491293 as a PET ligand in healthy adult volunteers.

Conditions

Healthy

Keywords

JNJ-42491293; JNJ-40411813; Metabotropic glutamate subtype 2 receptor (mGlu2R); Positive allosteric modulator (PAM); positron emission tomography (PET)

Outcome Measures

Primary Outcomes (5)

• Metabolism (uptake, distribution, and clearance) of [11C] JNJ-42491293 in brain (Part B)

  Up to approximately 8 days

• Adverse events (All Parts)

  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)

  Up to approximately 8 days

• Radiation dosimetry of [11C] JNJ-42491293 (Part A)

  Up to approximately 8 days

• Peripheral metabolism of [11C] JNJ-42491293 (Part B)

  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)

  Up to approximately 16 days (Part C); Up to approximately 9 days (Part D)

• Clearance rate of JNJ-40411813 from the brain (Part D)

  Up to approximately 9 days

Study Arms (1)

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.

Drug: [11C] JNJ-42491293; Drug: [11C] JNJ-42491293 + JNJ-40411813

Interventions

[11C] JNJ-42491293 DRUG

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.

001

[11C] JNJ-42491293 + JNJ-40411813 DRUG

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

001

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Interventions

1-butyl-3-chloro-4-(4-phenyl-1-piperidinyl)-(1H)-pyridone

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 25, 2011
• Study Start: December 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 22, 2011

Record last verified: 2011-07