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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-04995274

• Registration Number: NCT01173757
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-07-29
• Study Start: 2010-08
• Study First Posted: 2010-08-02
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PF-04995274	PF-04995274	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical examinations	up to 3 days
change from baseline in vital signs	up to 3 days
Singlet ECG post-dose	up to 3 days
Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma	up to 3 days
Adverse events	up to 3 days
Clinical safety laboratory endpoints	up to 3 days
Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma	up to 3 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States