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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01366287

Enrollment

Registered

2011-06-06

Start date

2011-01-31

Completion date

2011-02-28

Last updated

2011-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Relative bioavailability, food effect, tablet, suspension, single dose, crossover, healthy subjects

Brief summary

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.

Interventions

DRUGPF-03882845

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit.	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.	45 days	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026