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

Phase 1

Terminated

• Conditions: Bipolar Disorder; Depression
• Interventions: Drug: PF-04455242

• Registration Number: NCT00939887
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Study Start: 2009-09
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-04
• Last Update Posted: 2010-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	PF-04455242	-

Primary Outcome Measures

Name	Time	Method
Overall kappa opioid receptor occupancy of PF 04455242.	Study Day 1 and 2

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States