Overview

A Study Of PF-05175157 In Healthy Volunteers

Status:
Completed
Trial end date:
2011-05-01
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-05175157 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 45 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
measurements, 12-lead ECG and clinical laboratory tests.

- In addition, subjects must have normal chest x-ray, normal pulmonary function tests
and normal ophthalmological examination.

- Body Mass Index (BMI) of 17.5 to 29.5 kg/m2; and a total body weight > 50 kg (110
lbs).

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic
disease (including drug allergies).

- Evidence or history of any chronic ongoing or current pulmonary disease.

- History of smoking in the past 5 years or history or evidence of habitual use of other
(non-smoked) tobacco or nicotine-containing products within 3 months of Screening or
positive cotinine test at Screening or Day 0.

- Active ocular disease including infection, glaucoma, seasonal allergies, dry-eye
symptoms or retinal/optic nerve disease.

- Evidence or history of 'dry eye-syndrome', Meibomian gland disease, ocular
inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including
Lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular
lubricants, or use of contact lenses.