Status:
TERMINATED
A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)
Lead Sponsor:
Pfizer
Conditions:
Bipolar Disorder
Depression
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00939887
Start Date
September 1 2009
End Date
December 1 2009
Last Update
February 8 2010
Active Locations (3)
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1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
2
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
3
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520