Overview

A Single Dose Study Of PF-05161704 In Healthy Volunteers

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
Summary
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05161704 in healthy volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:

- Healthy male and/or female (non child-bearing potential) subjects between the ages of
18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities
identified by a detailed medical history, full physical examination, including blood
pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- 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.

- History or evidence of habitual use of tobacco or nicotine containing products within
3 months of Screening or positive cotinine test at screening or Day 0 of period one