NCT00990223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

1 month

First QC Date

October 5, 2009

Last Update Submit

December 19, 2020

Conditions

Healthy Volunteers

Keywords

Eplerenone Aldosterone and Plasma Renin Activity responses Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (1)

Cohort 1

EXPERIMENTAL

Healthy Volunteers - eplerenone versus placebo.

Drug: Eplerenone or Placebo

Interventions

Eplerenone or PlaceboDRUG

Eplerenone 100 mg or Placebo, daily for 10 days.

Cohort 1

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Related Publications (1)

  • Eudy RJ, Sahasrabudhe V, Sweeney K, Tugnait M, King-Ahmad A, Near K, Loria P, Banker ME, Piotrowski DW, Boustany-Kari CM. The use of plasma aldosterone and urinary sodium to potassium ratio as translatable quantitative biomarkers of mineralocorticoid receptor antagonism. J Transl Med. 2011 Oct 21;9:180. doi: 10.1186/1479-5876-9-180.

    PMID: 22017794DERIVED

Related Links

MeSH Terms

Interventions

Eplerenone

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 6, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 22, 2020

Record last verified: 2020-12

Locations

US(2)