A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)
This study has been terminated.
(This study was terminated on January 6, 2010, due to toxicology findings in animals exposed to PF-04455242 for three months.)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00939887
First received: July 13, 2009
Last updated: February 4, 2010
Last verified: February 2010
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| 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:
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 ]
| Enrollment: | 12 |
| Study Start Date: | September 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment |
Drug: PF-04455242
Single dose of up to 30 mg PF-04455242, delivered in capsule.
|
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
Locations
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06511-5473 | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06519 | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06520 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00939887 History of Changes |
| Other Study ID Numbers: | B1071003 |
| Study First Received: | July 13, 2009 |
| Last Updated: | February 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Analgesics, Opioid |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 16, 2013