Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00990223

Enrollment

Registered

2009-10-06

Start date

2009-10-31

Completion date

2009-11-30

Last updated

2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Eplerenone Aldosterone and Plasma Renin Activity responses Pharmacodynamics

Brief 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.

Interventions

DRUGEplerenone or Placebo

Eplerenone 100 mg or Placebo, daily for 10 days.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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 100 mg of eplerenone	11 days

Secondary

Measure	Time frame
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).	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.	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,	9 days
MR: Mineralcorticoid Receptor, ACTβ: Beta Actin) after administration of eplerenone or placebo. These results will not be included in the study report.	9 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026