Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00990223

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

9.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Eplerenone or Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

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 Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Healthy Volunteers - eplerenone versus placebo.	Drug: Eplerenone or Placebo Eplerenone 100 mg or Placebo, daily for 10 days.

Arm

Intervention/Treatment

Experimental: Cohort 1

Healthy Volunteers - eplerenone versus placebo.

Drug: Eplerenone or Placebo

Eplerenone 100 mg or Placebo, daily for 10 days.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Miami	Florida	United States	33143
2	Pfizer Investigational Site	South Miami	Florida	United States	33143

Sponsors and Collaborators

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

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT00990223

Other Study ID Numbers:

A6141115

First Posted:

Oct 6, 2009

Last Update Posted:

Dec 22, 2020

Last Verified:

Dec 1, 2020

Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Eplerenone Aldosterone and Plasma Renin Activity responses Pharmacodynamics

Additional relevant MeSH terms:

Eplerenone

Study Results

No Results Posted as of Dec 22, 2020