Status:
COMPLETED
A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00971802
Start Date
September 1 2009
End Date
February 1 2010
Last Update
February 23 2010
Active Locations (1)
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1
Pfizer Investigational Site
South Miami, Florida, United States, 33143