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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT01314898

Run by

Pfizer

People needed

12

Starts

2011-03-01

Expected to finish

2011-06-01

Last updated by the study team

2011-07-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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