A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT00971802
- Run by
- Pfizer
- People needed
- 50
- Starts
- 2009-09-01
- Expected to finish
- 2010-02-01
- Last updated by the study team
- 2010-02-23
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — South Miami, Florida, United States
Full record on ClinicalTrials.gov
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