To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
A Phase I, Healthy Volunteer Determination Of 5HT4 Receptor Occupancy Of PF-04995274, Using PET With Ligand [11C]PF-05127401.
1 other identifier
interventional
8
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Aug 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedFirst Posted
Study publicly available on registry
August 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJune 1, 2011
May 1, 2011
3 months
July 29, 2010
May 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Exposure response of overall 5HT4 receptor occupancy of PF-04995274
up to 3 days
5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain
up to 3 days
Secondary Outcomes (7)
Adverse events
up to 3 days
change from baseline in vital signs
up to 3 days
Singlet ECG post-dose
up to 3 days
Clinical safety laboratory endpoints
up to 3 days
Clinical examinations
up to 3 days
- +2 more secondary outcomes
Study Arms (1)
PF-04995274
EXPERIMENTALInterventions
Single dose of up to 5 mg PF-04995274, delivered in solution on study day 1
Eligibility Criteria
You may qualify if:
- healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (3)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Pfizer Investigational Site
New Haven, Connecticut, 06519, United States
Pfizer Investigational Site
New Haven, Connecticut, 06520, United States
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 29, 2010
First Posted
August 2, 2010
Study Start
August 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
June 1, 2011
Record last verified: 2011-05