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

June 2, 2011 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1070
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suspension/fasted
Drug: PF-03882845
25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition
Drug: PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition
Drug: PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition
Experimental: Tablet/fasted
Drug: PF-03882845
25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition
Drug: PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition
Drug: PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition
Experimental: Tablet/fed
Drug: PF-03882845
25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition
Drug: PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition
Drug: PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
predose and post each dose (24, 48 and 96 hour timepoints)
Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring.
Time Frame: 45 days
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 4, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimate)

June 6, 2011

Study Record Updates

Last Update Posted (Estimate)

June 6, 2011

Last Update Submitted That Met QC Criteria

June 2, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0171006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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