A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00939887
Recruitment Status : Terminated (This study was terminated on January 6, 2010, due to toxicology findings in animals exposed to PF-04455242 for three months.)
First Posted : July 15, 2009
Last Update Posted : February 8, 2010
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Brief Summary:
This is a subject blind, investigator and sponsor open, randomized study consisting of 2 parts. Up to 15 healthy subjects will be included in the study. In the first part of the study the test retest reliability of the radiotracer [11C] PF 04767135 binding in man will be assessed. In the second part of this study, using [11C] PF 04767135, kappa opioid receptor occupancy (RO) will be assessed in up to three cohorts of subjects.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Depression Drug: PF-04455242 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Phase 1, Healthy Volunteer Qualification Of Ligand [11C] PF-04767135 And Randomized Determination Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET
Study Start Date : September 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Drug: PF-04455242
Single dose of up to 30 mg PF-04455242, delivered in capsule.

Primary Outcome Measures :
  1. Overall kappa opioid receptor occupancy of PF 04455242. [ Time Frame: Study Day 1 and 2 ]

Secondary Outcome Measures :
  1. Binding potential (BP) of [11C] PF 04767135. [ Time Frame: Study Day 1 and 2 ]
  2. Kappa opioid receptor occupancy of PF 04455242 at regions of interest in man. [ Time Frame: Study Day 1 and 2 ]
  3. Relationship between plasma PF 04455242 concentration and kappa opioid receptor occupancy (IC50). [ Time Frame: Study Day 1 and 2 ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.)

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen at Screening or Day 0.
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men.
  • Use of tobacco- or nicotine-containing products within 3 months of screening.
  • Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication (excluding [11C]PF 04767135).
  • 12 lead ECG demonstrating QTc >450 msec at Screening.
  • Pregnant or nursing females; females of childbearing potential.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00939887

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00939887     History of Changes
Other Study ID Numbers: B1071003
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: February 8, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders