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

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-05212365 in healthy volunteers

Condition	Intervention	Phase
Healthy	Drug: PF-05212365	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-05212365 (SAM-531) In Healthy Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:

Exposure response of 5-HT6 Receptor Occupancy (RO) of PF-05212365 in the striatum of healthy adult subjects [ Time Frame: up to 4 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 4 days ] [ Designated as safety issue: Yes ]
Change from baseline in orthostatic blood pressure [ Time Frame: Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose ] [ Designated as safety issue: Yes ]
Change from baseline in supine blood pressure [ Time Frame: Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose ] [ Designated as safety issue: Yes ]
Change from baseline in Singlet ECG [ Time Frame: Baseline and 72 hrs post-dose ] [ Designated as safety issue: Yes ]
Clinically relevant levels of standard hemotology (e.g. Hemoglobin, Hematocrit RBC count), chemistry (e.g. BUN, Creatinine, fasting Glucose), and urinalysis (e.g. pH Glucose, Protein). [ Time Frame: Baseline and 72 hrs post-dose ] [ Designated as safety issue: Yes ]
Abnormal findings from standard physical examination [ Time Frame: Baseline and 72 hrs post-dose ] [ Designated as safety issue: No ]
Maximum concentration (Cmax) for PF-05212365 in plasma [ Time Frame: up to 4 days ] [ Designated as safety issue: No ]
Time at Cmax (Tmax) for PF-05212365 in plasma [ Time Frame: up to 4 days ] [ Designated as safety issue: No ]
Area under the concentration-time profile from time zero to the time of the last quantifiableconcentration (AUClast) for PF-05212365 in plasma [ Time Frame: up to 4 days ] [ Designated as safety issue: No ]
Average concentration during the first post-dose PET scan (Cavg (scan 1)) for PF-05212365 in plasma [ Time Frame: 2-4 hrs post-dose ] [ Designated as safety issue: No ]
Average concentration during the second post-dose PET scan (Cavg (scan 2)) for PF-05212365 in plasma [ Time Frame: 48-50 hrs post dose ] [ Designated as safety issue: No ]
Change from baseline in orthostatic pulse rate [ Time Frame: Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose ] [ Designated as safety issue: Yes ]
Change from baseline in supine pulse rate [ Time Frame: Baseline, -2.5, -1.5, -.5 pre-dose, and 2, 3, 4, 48, 49, 50 hrs post-dose ] [ Designated as safety issue: Yes ]
Abnormal findings from standard neurological examination [ Time Frame: Baseline and 72 hrs post-dose ] [ Designated as safety issue: Yes ]

Enrollment:	6
Study Start Date:	November 2010
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PF-05212365	Drug: PF-05212365 Single dose of up to 30 mg PF-05212365, delivered as 1 mg, 3 mg, and/or 5 mg on study day 1. Other Name: SAM-531

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253655

Locations

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Pfizer

Yale University

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01253655 History of Changes
Other Study ID Numbers:	B1961009
Study First Received:	November 2, 2010
Last Updated:	April 26, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Healthy Volunteers

ClinicalTrials.gov processed this record on May 23, 2013

To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers (3193A1-1103)