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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-03882845

Drug

25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition

Primary outcomes

PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit.

Time frame: predose and post each dose (24, 48 and 96 hour timepoints)

Post dose is measured at 24, 48 and 96 hours after dose.
Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring.

Time frame: 45 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Randomized, Open-Label, Single Dose, Crossover Study To Estimate The Relative Oral Bioavailability And Food Effect Of PF-03882845 In Healthy Adult Volunteers

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jun 6, 2011
Registry last updated: Jun 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed