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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01173757
First received: July 29, 2010
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Healthy
Drug: PF-04995274
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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.

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Exposure response of overall 5HT4 receptor occupancy of PF-04995274 [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
  • 5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: up to 3 days ] [ Designated as safety issue: Yes ]
  • change from baseline in vital signs [ Time Frame: up to 3 days ] [ Designated as safety issue: Yes ]
  • Singlet ECG post-dose [ Time Frame: up to 3 days ] [ Designated as safety issue: Yes ]
  • Clinical safety laboratory endpoints [ Time Frame: up to 3 days ] [ Designated as safety issue: Yes ]
  • Clinical examinations [ Time Frame: up to 3 days ] [ Designated as safety issue: Yes ]
  • Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]
  • Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: August 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04995274 Drug: PF-04995274
Single dose of up to 5 mg PF-04995274, delivered in solution on study day 1

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173757

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01173757     History of Changes
Other Study ID Numbers: B1661002
Study First Received: July 29, 2010
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Healthy Volunteers

ClinicalTrials.gov processed this record on October 22, 2014