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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01173757
• Collaborator: (none)
• Enrollment: 8
• Locations: 3
• Arm: 1
• Duration (Months): 3
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Aug 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Exposure response of overall 5HT4 receptor occupancy of PF-04995274 [up to 3 days]

2. 5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain [up to 3 days]

Secondary Outcome Measures

1. Adverse events [up to 3 days]

2. change from baseline in vital signs [up to 3 days]

3. Singlet ECG post-dose [up to 3 days]

4. Clinical safety laboratory endpoints [up to 3 days]

5. Clinical examinations [up to 3 days]

6. Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma [up to 3 days]

7. Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma [up to 3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511
2	Pfizer Investigational Site	New Haven	Connecticut	United States	06519
3	Pfizer Investigational Site	New Haven	Connecticut	United States	06520

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01173757
• Other Study ID Numbers: B1661002
• First Posted: Aug 2, 2010
• Last Update Posted: Jun 1, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: Healthy Volunteers

Study Results

No Results Posted as of Jun 1, 2011