Safety and Tolerability of Ascending Intravenous Doses of PF-05231023 In Adult Subjects With Type 2 Diabetes
Completed · Phase 1 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type 2
In brief
This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple ascending doses of PF-05231023.
Key facts
- Study ID
- NCT01396187
- Run by
- Pfizer
- People needed
- 50
- Starts
- 2011-07-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2015-01-12
Who can join
Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male subjects and female subjects of non-childbearing potential between the ages of 30 and 70 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines. Subjects who have other conditions but are well controlled by either diet or medications may be included as well (for example, a subject with high cholesterol level on appropriate treatment is eligible).
- Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight >50 kg (110 lbs).
You may not qualify if…
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Diagnosis of Type 1 diabetes mellitus.
- Evidence of diabetic complications with significant end organ damage
Where it is running
- Pfizer Investigational Site — Chula Vista, California, United States
- Pfizer Investigational Site — Miami, Florida, United States
- Pfizer Investigational Site — South Miami, Florida, United States
- Pfizer Investigational Site — Overland Park, Kansas, United States
- Pfizer Investigational Site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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