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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
History of Changes

March 3, 2011
July 5, 2011
March 2011
June 2011   (final data collection date for primary outcome measure)
Twenty-four hour urinary Na/K ratio (AUC(0-24)). [ Time Frame: 0-24hr postdose per period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01314898 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers
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.

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Volunteers
  • 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
Experimental: Treatment
Interventions:
  • Drug: 3 mg PF-03882845
  • Drug: 10 mg PF-03882845
  • Drug: 30 mg PF-03882845
  • Drug: 100 mg PF-03882845
  • Drug: Spironolactone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01314898
B0171007, B0171007
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP