Diabetes Mellitus, Type 2
Conditions
Keywords
Single Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects
Brief 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.
Interventions
One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects | 5 months |
| Single dose pharmacokinetics of PF-05175157 | 5 months |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory pharmacodynamic biomarkers | 5 months |
Countries
United States
Outcome results
None listed