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

NCT ID: NCT00971802

Last Updated: 2010-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Healthy volunteers - PF-03882845 versus Placebo

Group Type EXPERIMENTAL

PF-03882845 or Placebo

Intervention Type DRUG

PF-03882845 20 mg or Placebo, daily for 10 days.

Cohort 2

Healthy volunteers - PF-03882845 versus Placebo

Group Type EXPERIMENTAL

PF-03882845 or Placebo

Intervention Type DRUG

PF-03882845 60 mg or Placebo, daily for 10 days.

Cohort 3

Healthy volunteers - PF-03882845 versus Placebo

Group Type EXPERIMENTAL

PF-03882845 or Placebo

Intervention Type DRUG

PF-03882845 120 mg or Placebo, daily for 10 days.

Cohort 4

Healthy volunteers - PF-03882845 versus Placebo

Group Type EXPERIMENTAL

PF-03882845 or Placebo

Intervention Type DRUG

PF-03882845 185 mg or Placebo, daily for 10 days.

Interventions

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PF-03882845 or Placebo

PF-03882845 20 mg or Placebo, daily for 10 days.

Intervention Type DRUG

PF-03882845 or Placebo

PF-03882845 60 mg or Placebo, daily for 10 days.

Intervention Type DRUG

PF-03882845 or Placebo

PF-03882845 120 mg or Placebo, daily for 10 days.

Intervention Type DRUG

PF-03882845 or Placebo

PF-03882845 185 mg or Placebo, daily for 10 days.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

South Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0171008&StudyName=A%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%2C%20And%20Pharmacodynamics%20Of%20PF-03882845%20In%20Healthy%20Volunteers

To obtain contact information for a study center near you, click here.

Other Identifiers

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B0171008

Identifier Type: -

Identifier Source: org_study_id

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