Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Pfizer Yale University |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00730990 |
The primary purpose of this study is to assess central receptor occupancy of PF 03654746 at the H3 receptor after a single oral dose of PF 03654746.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Other: Positron Emission tomography Other: PET Scan with PF-03654746 |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Subject), Single Group Assignment, Pharmacokinetics Study |
Official Title: | A8801007 A Phase I, Healthy Volunteer Qualification Of Ligand [C 11] PF 04621053 And Randomized Determination Of H3 Receptor Occupancy Of PF 03654746, Using PET |
Enrollment: | 10 |
Study Start Date: | May 2008 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohort 1: Experimental
This arm will have no active treatment.
|
Other: Positron Emission tomography
Positron Emission tomography scans. Part 1of the study : 4 subjects will receive 2 scans a day for 1 day with PET ligand administered in tracer quantities.
|
Cohort 2: Experimental |
Other: PET Scan with PF-03654746
If none of the data from Cohort 2 is informative, then: 2) an additional 3 subjects will receive 2 Scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746. Doses will be determined based upon the outcome of the first intervention.
Other: PET Scan with PF-03654746
If none of the data from the previous interventions are informative, then: 3) an additional 3 patients will receive 2 scans on Day 1 and 1 scan on Day 2 following three different doses of PF-0365476. Doses will be determined based upon the outcomes of the previous interventions.
Other: PET Scan with PF-03654746
Part 2 of the study will have 3 possible interventions: 1) 3 subjects in Cohort 2 will receive 2 scans on Day 1 and 1 scan on Day 2 following 3 different doses of PF-03654746 (0.5 mg, 1.5 mg, 4 mg). |
Additional Study Purpose Details: To validate PET ligand which will be used to determine receptor occupancy and to determine receptor occupancy of PF-0367456
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Pfizer Investigational Site | |
New Haven, Connecticut, United States, 06511 | |
Pfizer Investigational Site | |
New Haven, Connecticut, United States, 06519 | |
Pfizer Investigational Site | |
New Haven, Connecticut, United States, 06520 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A8801007 |
Study First Received: | August 5, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00730990 |
Health Authority: | United States: Food and Drug Administration |
Positron Emission Tomography study in healthy volunteers for ligand qualification and receptor occupancy determination. |
Healthy |