Overview

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

Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Criteria
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.