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.

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

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-04995274

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • 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

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma	up to 3 days
Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma	up to 3 days

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

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: Healthy Volunteers
• Other Study ID Numbers: B1661002