Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862

Bayer

Status and phase: Completed; Phase 1

Conditions: Clinical Pharmacology

Treatments: Drug: Placebo; Drug: Finerenone (BAY 94-8862) PEG solution; Drug: Eplerenone (Inspra®); Drug: Finerenone (BAY 94-8862) immediate release tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01473108

2010-018500-90 (EudraCT Number)

13786

Details and patient eligibility

About

Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.

Full description

Clinical pharmacology

Enrollment: 67 patients

Sex: Male

Ages: 18 to 46 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male white subjects
• 18 to 46 years of age
• Body mass index (BMI): 18 - 29.9 kg/m²

Exclusion criteria

• Clinically relevant findings in medical history or in the physical examination
• Systolic blood pressure below 100 or above 140 mmHg
• Diastolic blood pressure below 50 or above 90 mmHg
• Heart rate below 45 or above 95 beats / min

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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67 participants in 5 patient groups

Finerenone (20 mg solution)

Experimental group

Description:

3-fold crossover of single dose 20 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.

Treatment:

Drug: Eplerenone (Inspra®)

Drug: Finerenone (BAY 94-8862) PEG solution

Drug: Placebo

Finerenone (10 mg solution)

Experimental group

Description:

3-fold crossover of single dose 10 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.

Treatment:

Drug: Eplerenone (Inspra®)

Drug: Finerenone (BAY 94-8862) PEG solution

Drug: Placebo

Finerenone (5 mg solution)

Experimental group

Description:

3-fold crossover of single dose 5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.

Treatment:

Drug: Eplerenone (Inspra®)

Drug: Finerenone (BAY 94-8862) PEG solution

Drug: Placebo

Finerenone (20 mg as tablets)

Experimental group

Description:

3-fold crossover of single dose 20 mg BAY 94-8862 as 2 x 10 mg tablet, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.

Treatment:

Drug: Eplerenone (Inspra®)

Drug: Finerenone (BAY 94-8862) immediate release tablet

Drug: Placebo

Finerenone (2.5 mg solution)

Experimental group

Description:

3-fold crossover of single dose 2.5 mg BAY 94-8862 solution, placebo and 50 mg eplerenone. The challenge drug fludrocortisone was given 2 h prior to administration of BAY 94-8862, eplerenone, and placebo.

Treatment:

Drug: Eplerenone (Inspra®)

Drug: Finerenone (BAY 94-8862) PEG solution

Drug: Placebo