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

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NCT01314898

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 11, 2011)		12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01314898
Other Study ID Numbers  ICMJE B0171007
B0171007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2011

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