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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Diabetes Melliuts, Type 2

Treatments: Drug: 100 mg PF-05231023; Other: Placebo; Drug: 150 mg PF-05231023; Drug: 25 mg PF-05231023; Drug: 50 mg PF-05231023

Study type: Interventional

Funder types: Industry

Identifiers

NCT01673178

B2901011

Details and patient eligibility

About

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

Enrollment: 107 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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107 participants in 5 patient groups, including a placebo group

Placebo Arm

Placebo Comparator group

Treatment:

Other: Placebo

25 mg

Experimental group

Treatment:

Drug: 25 mg PF-05231023

50 mg

Experimental group

Treatment:

Drug: 50 mg PF-05231023

100 mg

Experimental group

Treatment:

Drug: 100 mg PF-05231023

150 mg

Experimental group

Treatment:

Drug: 150 mg PF-05231023