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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01314898
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : July 6, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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.
Study Start Date : March 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Twenty-four hour urinary Na/K ratio (AUC(0-24)). [ Time Frame: 0-24hr postdose per period ]

Secondary Outcome Measures :
  1. 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 ]
  2. Time of Maximum concentration(Tmax) of PF-03882845. [ Time Frame: 0-24 hr post dose per period ]
  3. Maximum concentration (Cmax) of PF-03882845. [ Time Frame: 0-24 hr post dose per period ]
  4. Safety and tolerability: Physical examinations, adverse event monitoring, clinical safety laboratory assessments, vital sign measurements and 12-lead ECGs. [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01314898

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01314898     History of Changes
Other Study ID Numbers: B0171007
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: July 2011

Keywords provided by Pfizer:
Single dose
placebo control
antimineralocorticoid activity

Additional relevant MeSH terms:
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents