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Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

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: Eplerenone 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 changes in serum aldosterone and plasma renin activity on Day 0 and on Days 1 and 10 after administration of 100 mg of eplerenone daily for 10 days.

Clinical Details

Official title: A Phase 1, Double-Blind (Sponsor Open), Randomized, Placebo-Controlled Trial To Evaluate The Effects Of 100 MG Once Daily Of Eplerenone On Serum Aldesterone And Plasma Renin Activity During 10 Days Of Dosing In Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Area under the effect curve (AUEC) for serum aldosterone and PRA on Day 0 and on Days 1 and 10 after administration of 100 mg of eplerenone

Secondary outcome:

Single Dose PK for eplerenone: Cmax, Tmax, and AUCtau; Multiple Dose PK for eplerenone: Cmax(ss), Tmax(ss), AUC(,tau,ss), half life, Cmin(ss), Cave(ss), accumulation ratios AUC(tau,ss)/AUC(tau,sd) and Cmax(ss)/Cmax(sd).

Safety and tolerability of eplerenone as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations and ECGs.

Change from baseline (Day 0) to Day 8 in exploratory mRNA gene expression biomarkers (SGK1: Serum/glucocorticoid regulated kinase 1 gene, ENaCα: Epithelial Sodium Channel alpha subunit, ENaCγ: Epithelial Sodium Channel gamma subunit,

MR: Mineralcorticoid Receptor, ACTβ: Beta Actin) after administration of eplerenone 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

- Subjects with a supine BP greater than or equal to 140 mm Hg systolic or greater than

or equal to 90 mm Hg diastolic or <100 mm Hg systolic and <60 mm Hg diastolic on a single measurement, as described in the protocol

- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing

- History of sensitivity to eplerenone, spironolactone or related compounds.

- Serum potassium >5. 0 mEq/L at screening or Day 0

Locations and Contacts

Pfizer Investigational Site, Miami, Florida 33143, United States

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: October 2009
Last updated: February 16, 2011

Page last updated: August 23, 2015

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