A Study Of Three PF-05190457 Formulations In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: PF-05190457

Study type: Interventional

Funder types: Industry

Identifiers

NCT01522807

B3301007

Details and patient eligibility

About

The purpose of the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers.

Enrollment: 16 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males and females of non-childbearing potential between ages of 21 and 55 years, BMI of 17.5 to 30.5 kg/m^2, and weight above 50 kg.

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

100 mg PF-05190457

Experimental group

Description:

Three fasted treatments and fed with the short-duration osmotic capsule

Treatment:

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

100 mg PF - 05190457

Experimental group

Description:

Three fasted treatments and fed with the long-duration osmotic capsule

Treatment:

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457

Drug: PF-05190457