This Study Will 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:
Collaborator:
Yale University
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01258751
First received: December 9, 2010
Last updated: July 5, 2011
Last verified: July 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-05212377 in healthy volunteers


Condition Intervention Phase
Healthy
Drug: PF-05212377
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-Label Study To Evaluate 5-Ht6 Receptor Occupancy As Measured By Positron Emission Tomography (PET) With Ligand [11c]PF-04171252 Following Single Oral Dose Administration Of PF-05212377 (Sam-760) In Healthy Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To assess the central 5-HT6 receptor occupancy (RO) in the striatum in relation to systemic exposure of PF-05212377 after single oral administration in healthy adult subjects. [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: continuous, up to 8 days ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) for PF-05212377 in plasma [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Time at Cmax (Tmax) for PF-05212377 in plasma [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) for PF-05212377 in plasma [ Time Frame: up to 8 days ] [ Designated as safety issue: No ]
  • Average concentration during the first post-dose PET scan (Cavg (scan 1)) for PF-05212377 in plasma [ Time Frame: approximately 4-6 hrs post-dose ] [ Designated as safety issue: No ]
  • Average concentration during the second post-dose PET scan (Cavg (scan 2)) for PF-05212377 in plasma [ Time Frame: approximately 28-30 hrs post-dose ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: December 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-05212377 Drug: PF-05212377
Single dose of up to 70 mg PF-05212377, delivered as .25 mg, 5 mg and/or 15 mg on study day 1
Other Name: SAM-760

  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: NCT01258751

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Yale University
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: NCT01258751     History of Changes
Other Study ID Numbers: B2081007, B2081007
Study First Received: December 9, 2010
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Healthy Volunteers

ClinicalTrials.gov processed this record on October 19, 2014