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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar Disorder Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment

Group Type EXPERIMENTAL

PF-04455242

Intervention Type DRUG

Single dose of up to 30 mg PF-04455242, delivered in capsule.

Interventions

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PF-04455242

Single dose of up to 30 mg PF-04455242, delivered in capsule.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes