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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PF-03882845 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00971802

B0171008

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

50 participants in 4 patient groups

Cohort 1

Experimental group

Description:

Healthy volunteers - PF-03882845 versus Placebo

Treatment:

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo

Cohort 2

Experimental group

Description:

Healthy volunteers - PF-03882845 versus Placebo

Treatment:

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo

Cohort 3

Experimental group

Description:

Healthy volunteers - PF-03882845 versus Placebo

Treatment:

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo

Cohort 4

Experimental group

Description:

Healthy volunteers - PF-03882845 versus Placebo

Treatment:

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo

Drug: PF-03882845 or Placebo