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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
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 systolic or

- Serum potassium >=5.1 mmol/L or if deemed necessary.

- Estimated GFR individual parameters following at least 5 minutes of rest at Screening.

NCT01314898
Pfizer
Completed
A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers

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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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01314898
B0171007
B0171007
No
Not Provided
Not Provided
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

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