A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00939887

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 I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Single Group Assignment, Pharmacokinetics/Dynamics Study
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:

MedlinePlus related topics: Bipolar Disorder Depression

U.S. FDA Resources

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 ]

Estimated Enrollment:	15
Study Start Date:	September 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental Single dose of PF-04455242, delivered in capsule, dosage TBD	Drug: PF-04455242 Single dose of PF-04455242, delivered in capsule, dosage TBD

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

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1071003
Study First Received:	July 13, 2009
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00939887 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder
Mood Disorders

Psychotic Disorders
Healthy
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Affective Disorders, Psychotic
Depression
Mental Disorders

Bipolar Disorder
Mood Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 11, 2009