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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: 3 mg PF-03882845

Drug: 100 mg PF-03882845

Drug: 30 mg PF-03882845

Drug: Spironolactone

Drug: 10 mg PF-03882845

Study type

Interventional

Funder types

Industry

Identifiers

NCT01314898

B0171007

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.