A Study Of PF-05190457 In Healthy Volunteers And Type-2 Diabetic Patients

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses.

Key facts

Study ID

NCT01372163

Run by

Pfizer

People needed

35

Starts

2011-07-01

Expected to finish

2012-04-01

Last updated by the study team

2012-05-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 30.5 kg/m\^2, and weight between 50 and 100 kg, inclusive.
• Type 2 diabetic males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 40.0 kg/m\^2, weight between 50 and 150 kg, and HbA1c of 7.0-10.0%, inclusive.

You may not qualify if…

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
• Additionally, type 2 diabetic patients who have history of diabetic complications with significant end-organ damage or pharmacologic treatment for diabetes in addition to metformin.

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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