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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01314898

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: 3 mg PF-03882845 Drug: 10 mg PF-03882845 Drug: 30 mg PF-03882845 Drug: 100 mg PF-03882845 Drug: Spironolactone	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Twenty-four hour urinary Na/K ratio (AUC(0-24)). [0-24hr postdose per period]

Secondary Outcome Measures

Area Under the Curve(AUClast) from the time of dosing to the last data point of PF-03882845. [0-24 hr post dose per period]
Time of Maximum concentration(Tmax) of PF-03882845. [0-24 hr post dose per period]
Maximum concentration (Cmax) of PF-03882845. [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. [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.