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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: PF-03882845 or Placebo

• Registration Number: NCT00971802
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Status Verified: 2010-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-22
• Last Update Posted: 2010-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 4	PF-03882845 or Placebo	Healthy volunteers - PF-03882845 versus Placebo
Cohort 3	PF-03882845 or Placebo	Healthy volunteers - PF-03882845 versus Placebo
Cohort 1	PF-03882845 or Placebo	Healthy volunteers - PF-03882845 versus Placebo
Cohort 2	PF-03882845 or Placebo	Healthy volunteers - PF-03882845 versus Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 South Miami, Florida, United States