A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)
Stopped early · Phase 1
Conditions studied: Bipolar Disorder, Depression
In brief
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.
Key facts
- Study ID
- NCT00939887
- Run by
- Pfizer
- People needed
- 12
- Starts
- 2009-09-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2010-02-08
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.)
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — New Haven, Connecticut, United States
- Pfizer Investigational Site — New Haven, Connecticut, United States
- Pfizer Investigational Site — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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