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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01314898
First received: March 3, 2011
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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
cross-over
active-control
placebo control
antimineralocorticoid activity

Additional relevant MeSH terms:
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014