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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: PF-03882845 or Placebo (Drug); PF-03882845 or Placebo (Drug); PF-03882845 or Placebo (Drug); PF-03882845 or Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome:

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)

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.

Secondary outcome:

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, South Miami, Florida 33143, United States
Additional Information

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

Starting date: September 2009
Last updated: February 22, 2010

Page last updated: August 23, 2015

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