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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537497
• Other study ID #: B1731013
• Status: Completed
• Phase: Phase 1
• First received: February 17, 2012
• Last updated: July 6, 2012
• Start date: March 2012
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modulation of carbohydrate and lipid metabolism		24 hours	No
Secondary	Cmax of PF-05175157 after single oral doses		24 hours	No
Secondary	Tmax of PF-05175157 after single oral doses		24 hours	No
Secondary	Area under the curve (AUC) of PF-05175157 after single oral doses		24 hours	No

External Links

•   To obtain contact information for a study center near you, click here.