Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990223
• Other study ID #: A6141115
• Status: Completed
• Phase: Phase 1
• Start date: October 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Eplerenone or Placebo
Eplerenone 100 mg or Placebo, daily for 10 days.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change from baseline (Day 0) to Day 8 in exploratory mRNA gene expression biomarkers (SGK1: Serum/glucocorticoid regulated kinase 1 gene, ENaCa: Epithelial Sodium Channel alpha subunit, ENaC?: Epithelial Sodium Channel gamma subunit,		9 days
Secondary	MR: Mineralcorticoid Receptor, ACTß: Beta Actin) after administration of eplerenone or placebo. These results will not be included in the study report.		9 days

External Links

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