Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Eplerenone or PlaceboDRUG

Eplerenone 100 mg or Placebo, daily for 10 days.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (2)

Pfizer Investigational Site

Miami, Florida, United States

Pfizer Investigational Site

South Miami, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 11 days

Secondary Outcomes

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).

Time frame: 13 days

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.

Time frame: 13 days

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,

Time frame: 9 days

MR: Mineralcorticoid Receptor, ACTβ: Beta Actin) after administration of eplerenone or placebo. These results will not be included in the study report.

Time frame: 9 days

Data from ClinicalTrials.gov

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