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

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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: PF-03882845 or Placebo; Drug: PF-03882845 or Placebo; Drug: PF-03882845 or Placebo; Drug: PF-03882845 or Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • South Miami, Florida, United States, 33143
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Healthy volunteers - PF-03882845 versus Placebo	Drug: PF-03882845 or Placebo; PF-03882845 20 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 60 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 120 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 185 mg or Placebo, daily for 10 days.
Experimental: Cohort 2; Healthy volunteers - PF-03882845 versus Placebo	Drug: PF-03882845 or Placebo; PF-03882845 20 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 60 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 120 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 185 mg or Placebo, daily for 10 days.
Experimental: Cohort 3; Healthy volunteers - PF-03882845 versus Placebo	Drug: PF-03882845 or Placebo; PF-03882845 20 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 60 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 120 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 185 mg or Placebo, daily for 10 days.
Experimental: Cohort 4; Healthy volunteers - PF-03882845 versus Placebo	Drug: PF-03882845 or Placebo; PF-03882845 20 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 60 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 120 mg or Placebo, daily for 10 days.; Drug: PF-03882845 or Placebo; PF-03882845 185 mg or Placebo, daily for 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	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.	13 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 3, 2009
• First Submitted That Met QC Criteria: September 3, 2009
• First Posted (Estimate): September 4, 2009

Study Record Updates

• Last Update Posted (Estimate): February 23, 2010
• Last Update Submitted That Met QC Criteria: February 22, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: B0171008