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

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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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

12 participants in 1 patient group

Treatment
Experimental group
Treatment:
Drug: Spironolactone
Drug: 10 mg PF-03882845
Drug: 30 mg PF-03882845
Drug: 100 mg PF-03882845
Drug: 3 mg PF-03882845

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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