- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01173757
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
May 31, 2011 updated by: Pfizer
A Phase I, Healthy Volunteer Determination Of 5HT4 Receptor Occupancy Of PF-04995274, Using PET With Ligand [11C]PF-05127401.
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-04995274 in healthy volunteers.
Study Overview
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Pfizer Investigational Site
-
New Haven, Connecticut, United States, 06519
- Pfizer Investigational Site
-
New Haven, Connecticut, United States, 06520
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PF-04995274
|
Single dose of up to 5 mg PF-04995274, delivered in solution on study day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exposure response of overall 5HT4 receptor occupancy of PF-04995274
Time Frame: up to 3 days
|
up to 3 days
|
5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain
Time Frame: up to 3 days
|
up to 3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: up to 3 days
|
up to 3 days
|
change from baseline in vital signs
Time Frame: up to 3 days
|
up to 3 days
|
Singlet ECG post-dose
Time Frame: up to 3 days
|
up to 3 days
|
Clinical safety laboratory endpoints
Time Frame: up to 3 days
|
up to 3 days
|
Clinical examinations
Time Frame: up to 3 days
|
up to 3 days
|
Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma
Time Frame: up to 3 days
|
up to 3 days
|
Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma
Time Frame: up to 3 days
|
up to 3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
July 29, 2010
First Submitted That Met QC Criteria
July 29, 2010
First Posted (Estimate)
August 2, 2010
Study Record Updates
Last Update Posted (Estimate)
June 1, 2011
Last Update Submitted That Met QC Criteria
May 31, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B1661002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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