A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption

Pfizer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: PF-03882845

Study type: Interventional

Funder types: Industry

Identifiers

NCT01366287

B0171006

Details and patient eligibility

About

The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between the ages of 18 and 55 years,Females must be of non-childbearing potential. Body mass index of 17.5 to 30.5 kg/m2.
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

• Serum potassium >5 mEq/L at screening.
• Impaired kidney function (estimated GFR <60 mL/min/1.73 m2). History of sensitivity to eplerenone, spironolactone, or related compounds.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Suspension/fasted

Experimental group

Treatment:

Drug: PF-03882845

Drug: PF-03882845

Drug: PF-03882845

Tablet/fasted

Experimental group

Treatment:

Drug: PF-03882845

Drug: PF-03882845

Drug: PF-03882845

Tablet/fed

Experimental group

Treatment:

Drug: PF-03882845

Drug: PF-03882845

Drug: PF-03882845