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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
3 mg PF-03882845, single oral dose
10 mg PF-03882845, single oral dose
30 mg PF-03882845, single oral dose
Pfizer Investigational Site
New Haven, Connecticut, United States
Twenty-four hour urinary Na/K ratio (AUC(0-24)).
Time frame: 0-24hr postdose per period
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
Time of Maximum concentration(Tmax) of PF-03882845.
Time frame: 0-24 hr post dose per period
Maximum concentration (Cmax) of PF-03882845.
Time frame: 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
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100 mg PF-03882845, single oral dose
100 mg spironolactone, single oral dose