This Study Will Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
This study has been completed.
Sponsor:
Pfizer
Collaborator:
Yale University
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01258751
First received: December 9, 2010
Last updated: July 5, 2011
Last verified: July 2011
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Purpose
The purpose of this study is to evaluate the relationship between plasma drug levels and receptor binding in brain using PET; and to evaluate safety and tolerability after a single administration of PF-05212377 in healthy volunteers
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-05212377 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Phase 1, Open-Label Study To Evaluate 5-Ht6 Receptor Occupancy As Measured By Positron Emission Tomography (PET) With Ligand [11c]PF-04171252 Following Single Oral Dose Administration Of PF-05212377 (Sam-760) In Healthy Subjects |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To assess the central 5-HT6 receptor occupancy (RO) in the striatum in relation to systemic exposure of PF-05212377 after single oral administration in healthy adult subjects. [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: continuous, up to 8 days ] [ Designated as safety issue: Yes ]
- Maximum concentration (Cmax) for PF-05212377 in plasma [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
- Time at Cmax (Tmax) for PF-05212377 in plasma [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
- Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) for PF-05212377 in plasma [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
- Average concentration during the first post-dose PET scan (Cavg (scan 1)) for PF-05212377 in plasma [ Time Frame: approximately 4-6 hrs post-dose ] [ Designated as safety issue: No ]
- Average concentration during the second post-dose PET scan (Cavg (scan 2)) for PF-05212377 in plasma [ Time Frame: approximately 28-30 hrs post-dose ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | December 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-05212377 |
Drug: PF-05212377
Single dose of up to 70 mg PF-05212377, delivered as .25 mg, 5 mg and/or 15 mg on study day 1
Other Name: SAM-760
|
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 nonchildbearing potential between the ages of 18 and 55 years, inclusive
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening
- Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258751
Locations
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06519 | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06520 | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06511 | |
Sponsors and Collaborators
Pfizer
Yale University
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: | NCT01258751 History of Changes |
| Other Study ID Numbers: | B2081007, B2081007 |
| Study First Received: | December 9, 2010 |
| Last Updated: | July 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Healthy Volunteers |
ClinicalTrials.gov processed this record on May 16, 2013