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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment

Group Type EXPERIMENTAL

3 mg PF-03882845

Intervention Type DRUG

3 mg PF-03882845, single oral dose

10 mg PF-03882845

Intervention Type DRUG

10 mg PF-03882845, single oral dose

30 mg PF-03882845

Intervention Type DRUG

30 mg PF-03882845, single oral dose

100 mg PF-03882845

Intervention Type DRUG

100 mg PF-03882845, single oral dose

Spironolactone

Intervention Type DRUG

100 mg spironolactone, single oral dose

Interventions

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3 mg PF-03882845

3 mg PF-03882845, single oral dose

Intervention Type DRUG

10 mg PF-03882845

10 mg PF-03882845, single oral dose

Intervention Type DRUG

30 mg PF-03882845

30 mg PF-03882845, single oral dose

Intervention Type DRUG

100 mg PF-03882845

100 mg PF-03882845, single oral dose

Intervention Type DRUG

Spironolactone

100 mg spironolactone, single oral dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes