Clinical trial NCT01258751: This Study Will Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Yale University
First posted: 2010-12-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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-05212377 in healthy volunteers


Eligibility 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

Primary outcomes:
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.
timeFrame: up to 8 days
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: continuous, up to 8 days
measure: Maximum concentration (Cmax) for PF-05212377 in plasma
timeFrame: up to 8 days
measure: Time at Cmax (Tmax) for PF-05212377 in plasma
timeFrame: up to 8 days
measure: Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) for PF-05212377 in plasma
timeFrame: up to 8 days
measure: Average concentration during the first post-dose PET scan (Cavg (scan 1)) for PF-05212377 in plasma
timeFrame: approximately 4-6 hrs post-dose
measure: Average concentration during the second post-dose PET scan (Cavg (scan 2)) for PF-05212377 in plasma
timeFrame: approximately 28-30 hrs post-dose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: