A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers

July 5, 2011 updated by: Pfizer

A Phase 1, Double-Blind (Sponsor-Open), Placebo- And Active-Controlled, Single Dose, Crossover Study To Assess Antimineralocorticoid Activity Of Oral Pf-03882845 In Healthy Subjects.

24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid activity. The dose-response relationship of the antimineralocorticoid activity of PF-03882845 can be established following single oral doses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • 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:

  • Male and/or female healthy volunteers, age 18 to 55 years. Females must be of non-childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, diet restrictions and other trial procedures.

Exclusion Criteria:

  • Subjects with a supine BP >140 mm Hg systolic or >90 mm Hg diastolic or <100 mm Hg systolic or <60 mm Hg diastolic based on the average of the triplicate
  • Serum potassium >=5.1 mmol/L or <3.5 mmol/L at screening, confirmed by a single repeat if deemed necessary.
  • Estimated GFR <60 mL/min/1.73 m2 using the Cockcroft-Gault formula measurement of the individual parameters following at least 5 minutes of rest at Screening.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Drug: 3 mg PF-03882845
3 mg PF-03882845, single oral dose
Drug: 10 mg PF-03882845
10 mg PF-03882845, single oral dose
Drug: 30 mg PF-03882845
30 mg PF-03882845, single oral dose
Drug: 100 mg PF-03882845
100 mg PF-03882845, single oral dose
Drug: Spironolactone
100 mg spironolactone, single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Twenty-four hour urinary Na/K ratio (AUC(0-24)).
Time Frame: 0-24hr postdose per period
0-24hr postdose per period

Secondary Outcome Measures

Outcome Measure
Time Frame
Area Under the Curve(AUClast) from the time of dosing to the last data point of PF-03882845.
Time Frame: 0-24 hr post dose per period
0-24 hr post dose per period
Time of Maximum concentration(Tmax) of PF-03882845.
Time Frame: 0-24 hr post dose per period
0-24 hr post dose per period
Maximum concentration (Cmax) of PF-03882845.
Time Frame: 0-24 hr post dose per period
0-24 hr post dose per period
Safety and tolerability: Physical examinations, adverse event monitoring, clinical safety laboratory assessments, vital sign measurements and 12-lead ECGs.
Time Frame: 2 months
2 months

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

March 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 3, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 5, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0171007

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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