To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01173757
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : June 1, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-04995274 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase I, Healthy Volunteer Determination Of 5HT4 Receptor Occupancy Of PF-04995274, Using PET With Ligand [11C]PF-05127401.
Study Start Date : August 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: PF-04995274 Drug: PF-04995274
Single dose of up to 5 mg PF-04995274, delivered in solution on study day 1

Primary Outcome Measures :
  1. Exposure response of overall 5HT4 receptor occupancy of PF-04995274 [ Time Frame: up to 3 days ]
  2. 5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain [ Time Frame: up to 3 days ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: up to 3 days ]
  2. change from baseline in vital signs [ Time Frame: up to 3 days ]
  3. Singlet ECG post-dose [ Time Frame: up to 3 days ]
  4. Clinical safety laboratory endpoints [ Time Frame: up to 3 days ]
  5. Clinical examinations [ Time Frame: up to 3 days ]
  6. Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma [ Time Frame: up to 3 days ]
  7. Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma [ Time Frame: up to 3 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01173757

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
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01173757     History of Changes
Other Study ID Numbers: B1661002
First Posted: August 2, 2010    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011

Keywords provided by Pfizer:
Healthy Volunteers