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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: March 3, 2011
Last updated: July 5, 2011
Last verified: July 2011

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.

Condition Intervention Phase
Healthy Volunteers
Drug: 3 mg PF-03882845
Drug: 10 mg PF-03882845
Drug: 30 mg PF-03882845
Drug: 100 mg PF-03882845
Drug: Spironolactone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Twenty-four hour urinary Na/K ratio (AUC(0-24)). [ Time Frame: 0-24hr postdose per period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Time of Maximum concentration(Tmax) of PF-03882845. [ Time Frame: 0-24 hr post dose per period ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) of PF-03882845. [ Time Frame: 0-24 hr post dose per period ] [ Designated as safety issue: No ]
  • Safety and tolerability: Physical examinations, adverse event monitoring, clinical safety laboratory assessments, vital sign measurements and 12-lead ECGs. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: 3 mg PF-03882845
3 mg PF-03882845, single oral dose
Drug: 10 mg PF-03882845
10 mg PF-03882845, single oral dose
Drug: 30 mg PF-03882845
30 mg PF-03882845, single oral dose
Drug: 100 mg PF-03882845
100 mg PF-03882845, single oral dose
Drug: Spironolactone
100 mg spironolactone, single oral dose


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314898

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01314898     History of Changes
Other Study ID Numbers: B0171007, B0171007
Study First Received: March 3, 2011
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Single dose
placebo control
antimineralocorticoid activity

Additional relevant MeSH terms:
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014