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

Status:	Completed
Conditions:	Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	30 - 70
Updated:	10/3/2013
Start Date:	October 2012
End Date:	August 2013
Contact:	Pfizer CT.gov Call Center
Phone:	1-800-718-1021

A Phase 1, Placebo-Controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple IV Doses Of PF-05231023 In Obese Hyperlipidemic Adult Subjects With And Without Type 2 Diabetes Mellitus On A Background Of Atorvastatin

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

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

We found this trial at

sites

Pfizer Investigational Site

Asheville, North Carolina 28801

from

Asheville, NC