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

Phase 1 Four-Arm Parallel Group, Placebo-Controlled Study To Evaluate The Effects Of Single Doses Of PF- 05175157 At Three Dose Levels On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01537497

Enrollment

Registered

2012-02-23

Start date

2012-03-31

Completion date

2012-05-31

Last updated

2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Phase 1, Single Doses, Pharmacodynamics, Healthy Volunteers

Brief summary

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

Interventions

DRUGPF-05175157

One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.

DRUGPlacebo

One single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Modulation of carbohydrate and lipid metabolism	24 hours

Secondary

Measure	Time frame
Cmax of PF-05175157 after single oral doses	24 hours
Tmax of PF-05175157 after single oral doses	24 hours
Area under the curve (AUC) of PF-05175157 after single oral doses	24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026