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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Single-Dose PK for PF-03382845: Cmax(ss), Tmax(ss), AUC(tau,ss), half life, Cmin(ss), Cave(ss), Ae%, CL/F, V/F, CL renal; accumulation ratios AUC(tau,ss)/AUC(tau,sd) and Cmax(ss)/Cmax(sd)
Study Overview
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 Healthy Volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Cohort 1
Healthy volunteers - PF-03882845 versus Placebo
Intervention: PF-03882845 or Placebo (Drug)
Cohort 2
Healthy volunteers - PF-03882845 versus Placebo
Intervention: PF-03882845 or Placebo (Drug)
Cohort 3
Healthy volunteers - PF-03882845 versus Placebo
Intervention: PF-03882845 or Placebo (Drug)
Cohort 4
Healthy volunteers - PF-03882845 versus Placebo
Intervention: PF-03882845 or Placebo (Drug)
Outcomes
Primary Outcomes
Single-Dose PK for PF-03382845: Cmax(ss), Tmax(ss), AUC(tau,ss), half life, Cmin(ss), Cave(ss), Ae%, CL/F, V/F, CL renal; accumulation ratios AUC(tau,ss)/AUC(tau,sd) and Cmax(ss)/Cmax(sd)
Time Frame: 13 days
Safety and tolerability of PF-03382845 as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations, electrocardiograms (ECGs) and potential sex hormone mediators.
Time Frame: 13 days
Secondary Outcomes
- Area under the effect curve (AUEC) for serum aldosterone and PRA on Day 0 and on Days 1 and 10 after administration of PF-03882845(11 days)
- Change from baseline(Day 0) to Day8 in exploratory mRNA gene expression biomarkers (SGK1:Sodium-and Serum/glucocorticoid regulated kinase 1 gene,ENaCα:Epithelial Sodium Channel alpha subunit,ENaCγ:Epithelial Sodium Channel gamma(9 days)
- subunit,MR: Mineral corticoid Receptor,ACTβ:Beta Actin) after administration of PF-03882845 or placebo.These results will not be included in the study report(9 days)