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

Pfizer6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PF-05212365DRUG

Single dose of up to 30 mg PF-05212365, delivered as 1 mg, 3 mg, and/or 5 mg on study day 1.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Pfizer Investigational Site

New Haven, Connecticut, United States

Pfizer Investigational Site

New Haven, Connecticut, United States

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Exposure response of 5-HT6 Receptor Occupancy (RO) of PF-05212365 in the striatum of healthy adult subjects

Time frame: up to 4 days

Secondary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: continuous, up to 4 days

Change from baseline in orthostatic blood pressure

Time frame: Baseline, -5 pre-dose, and 5, 51, and 72 hrs post-dose

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

Change from baseline in Singlet ECG

Time frame: Baseline and 72 hrs post-dose

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

Abnormal findings from standard physical examination

Time frame: Baseline and 72 hrs post-dose

Maximum concentration (Cmax) for PF-05212365 in plasma

Time frame: up to 4 days

Time at Cmax (Tmax) for PF-05212365 in plasma

Time frame: up to 4 days

Area under the concentration-time profile from time zero to the time of the last quantifiableconcentration (AUClast) for PF-05212365 in plasma

Data from ClinicalTrials.gov

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