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

December 9, 2010
July 5, 2011
December 2010
May 2011   (final data collection date for primary outcome measure)
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 ]
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 5 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01258751 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: continuous, up to 5 days ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) for PF-05212377 in plasma [ Time Frame: up to 5 days ] [ Designated as safety issue: No ]
  • Time at Cmax (Tmax) for PF-05212377 in plasma [ Time Frame: up to 5 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 5 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 ]
Not Provided
Not Provided
 
This Study Will Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
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
Experimental: PF-05212377
Intervention: Drug: PF-05212377
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01258751
B2081007, B2081007
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Yale University
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP