Effects Of Eplerenone On Serum Aldesterone And Plasma Renin Activity

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Eplerenone or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00990223

A6141115

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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20 participants in 1 patient group

Cohort 1

Experimental group

Description:

Healthy Volunteers - eplerenone versus placebo.

Treatment:

Drug: Eplerenone or Placebo