Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Melliuts, Type 2

In brief

This is a trial in obese subjects who have poor lipid control with and without Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of PF-05231023

Key facts

Study ID

NCT01673178

Run by

Pfizer

People needed

107

Starts

2012-10-01

Expected to finish

2013-09-01

Last updated by the study team

2015-02-16

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects of non-childbearing potential between the ages of 30 and 70 years with and without a diagnosis of Type 2 diabetes mellitus (according to the American Diabetes Association guidelines).
• Subjects with poor lipid control as confirmed by laboratory tests.
• BMI of 30 to 40 Kg/m2 and a total body weight of >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 asymptomatic, seasonal allergies at time of dosing).
• Levels of blood enzymes indicating pancreatitis or elevated liver function enzymes outside of the laboratory's reference range as confirmed by laboratory tests.
• Subjects with Type 1 Diabetes Mellitus.

Where it is running

• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Profil Institute for Clinical Research, Inc. — Chula Vista, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Elite Research Institute — Miami, Florida, United States
• Miami Research Associates, Inc. — South Miami, Florida, United States
• MRA Clinical Research, LLC — South Miami, Florida, United States
• Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
• L-MARC Research Center — Louisville, Kentucky, United States
• Prism Research — Saint Paul, Minnesota, United States
• High Point Clinical Trials Center, LLC — High Point, North Carolina, United States
• Carolina Phase 1 Research — Raleigh, North Carolina, United States
• Wake Internal Medicine Consultants — Raleigh, North Carolina, United States
• Medpace Clinical Pharmacology Unit — Cincinnati, Ohio, United States
• Community Research — Cincinnati, Ohio, United States
• Mercy Hospital Pharmacy — Cincinnati, Ohio, United States
• Covance Clinical Research Unit — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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