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

This study has been terminated.
(This study was terminated on January 6, 2010, due to toxicology findings in animals exposed to PF-04455242 for three months.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00939887
First received: July 13, 2009
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Bipolar Disorder
Depression
Drug: PF-04455242
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall kappa opioid receptor occupancy of PF 04455242. [ Time Frame: Study Day 1 and 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Binding potential (BP) of [11C] PF 04767135. [ Time Frame: Study Day 1 and 2 ] [ Designated as safety issue: No ]
  • Kappa opioid receptor occupancy of PF 04455242 at regions of interest in man. [ Time Frame: Study Day 1 and 2 ] [ Designated as safety issue: No ]
  • Relationship between plasma PF 04455242 concentration and kappa opioid receptor occupancy (IC50). [ Time Frame: Study Day 1 and 2 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: PF-04455242
Single dose of up to 30 mg PF-04455242, delivered in capsule.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939887

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00939887     History of Changes
Other Study ID Numbers: B1071003
Study First Received: July 13, 2009
Last Updated: February 4, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 22, 2014