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A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
South Miami, Florida, 33143 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Male
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

- 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, and other study procedures.

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

- Evidence or history of clinically significant disease.

- Past medical history of epididymitis, orchitis, sexually transmitted diseases
(chlamydia, gonorrhea, etc.) or urinary tract infection.

- History of prostatitis or prostate surgery.

- Urinary catheterization or instrumentation within 12 months of screening. Inguinal or
scrotal hernia.

- Current or history of congenital genital abnormalities.

- Baseline scrotal ultrasound scan showing unilateral or bilateral scrotal blood flow
abnormalities or anatomic abnormalities (hydrocele, cysts, other), with the exception
of small epididymal cysts and spermatoceles.

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

- History of sensitivity to spironolactone, eplerenone, or related compounds.

- Serum potassium >5.5 mEq/L at screening or Day 0.

NCT00971802
Pfizer
Completed
A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers

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A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers
A Phase 1, Double-Blind (Sponsor Open), Randomized, Placebo- Controlled, Parallel Group, Oral Multiple-Dose Trial to Evaluate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF-03882845 in Healthy Volunteers
To evaluate the safety and tolerability of PF-03882845 in Healthy Volunteers. To evaluate the pharmacokinetics of PF-03882845 in Healthy Volunteers. To evaluate the pharmacodynamics of PF-03882845 in Healthy Volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Healthy Volunteers
  • Drug: PF-03882845 or Placebo
    PF-03882845 20 mg or Placebo, daily for 10 days.
  • Drug: PF-03882845 or Placebo
    PF-03882845 60 mg or Placebo, daily for 10 days.
  • Drug: PF-03882845 or Placebo
    PF-03882845 120 mg or Placebo, daily for 10 days.
  • Drug: PF-03882845 or Placebo
    PF-03882845 185 mg or Placebo, daily for 10 days.
  • Experimental: Cohort 1
    Healthy volunteers - PF-03882845 versus Placebo
    Intervention: Drug: PF-03882845 or Placebo
  • Experimental: Cohort 2
    Healthy volunteers - PF-03882845 versus Placebo
    Intervention: Drug: PF-03882845 or Placebo
  • Experimental: Cohort 3
    Healthy volunteers - PF-03882845 versus Placebo
    Intervention: Drug: PF-03882845 or Placebo
  • Experimental: Cohort 4
    Healthy volunteers - PF-03882845 versus Placebo
    Intervention: Drug: PF-03882845 or Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant disease.
  • Past medical history of epididymitis, orchitis, sexually transmitted diseases (chlamydia, gonorrhea, etc.) or urinary tract infection.
  • History of prostatitis or prostate surgery.
  • Urinary catheterization or instrumentation within 12 months of screening. Inguinal or scrotal hernia.
  • Current or history of congenital genital abnormalities.
  • Baseline scrotal ultrasound scan showing unilateral or bilateral scrotal blood flow abnormalities or anatomic abnormalities (hydrocele, cysts, other), with the exception of small epididymal cysts and spermatoceles.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
  • History of sensitivity to spironolactone, eplerenone, or related compounds.
  • Serum potassium >5.5 mEq/L at screening or Day 0.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00971802
B0171008
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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