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.
Drug: 3 mg PF-03882845
Drug: 10 mg PF-03882845
Drug: 30 mg PF-03882845
Drug: 100 mg PF-03882845
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Locations near you
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Full eligibility criteria for NCT01314898
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01314898
United States (1)
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
View full eligibility
Tris trial is registered with FDA with number: NCT01314898. The sponsor of the trial is Pfizer and it is looking for 12 volunteers for the current phase.
Official trial 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.
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