A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: PF-05175157

Study type: Interventional

Funder types: Industry

Identifiers

NCT01537497

B1731013

Details and patient eligibility

About

The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion in healthy volunteers

Enrollment: 31 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female 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. In addition, subjects must have normal pulmonary function tests and normal ocular findings.
• Women must be of non-childbearing potential.
• Body Mass Index (BMI) of 19.5 35.5 kg/m2, and a total body weight of > 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 and seasonal allergies at time of dosing).
• 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 -7.
• Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 4 patient groups, including a placebo group

100 mg PF-05175157

Experimental group

Description:

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Treatment:

Drug: PF-05175157

Drug: PF-05175157

Drug: PF-05175157

250 mg PF-05175157

Experimental group

Description:

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Treatment:

Drug: PF-05175157

Drug: PF-05175157

Drug: PF-05175157

600 mg PF-05175157

Experimental group

Description:

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Treatment:

Drug: PF-05175157

Drug: PF-05175157

Drug: PF-05175157

Placebo

Placebo Comparator group

Description:

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Treatment:

Drug: Placebo