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

NCT ID: NCT01473108

Last Updated: 2022-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-29

Study Completion Date

2011-05-17

Brief Summary

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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.

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Detailed Description

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Clinical pharmacology

Conditions

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Clinical Pharmacology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Finerenone (20 mg as tablets)

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.

Group Type EXPERIMENTAL

Finerenone (BAY 94-8862) immediate release tablet

Intervention Type DRUG

20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets

Eplerenone (Inspra®)

Intervention Type DRUG

Single oral dose of 50 mg eplerenone

Placebo

Intervention Type DRUG

Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

Finerenone (2.5 mg solution)

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.

Group Type EXPERIMENTAL

Finerenone (BAY 94-8862) PEG solution

Intervention Type DRUG

2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862

Eplerenone (Inspra®)

Intervention Type DRUG

Single oral dose of 50 mg eplerenone

Placebo

Intervention Type DRUG

Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

Finerenone (20 mg solution)

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.

Group Type EXPERIMENTAL

Finerenone (BAY 94-8862) PEG solution

Intervention Type DRUG

2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862

Eplerenone (Inspra®)

Intervention Type DRUG

Single oral dose of 50 mg eplerenone

Placebo

Intervention Type DRUG

Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

Finerenone (10 mg solution)

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.

Group Type EXPERIMENTAL

Finerenone (BAY 94-8862) PEG solution

Intervention Type DRUG

2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862

Eplerenone (Inspra®)

Intervention Type DRUG

Single oral dose of 50 mg eplerenone

Placebo

Intervention Type DRUG

Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

Finerenone (5 mg solution)

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.

Group Type EXPERIMENTAL

Finerenone (BAY 94-8862) PEG solution

Intervention Type DRUG

2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862

Eplerenone (Inspra®)

Intervention Type DRUG

Single oral dose of 50 mg eplerenone

Placebo

Intervention Type DRUG

Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

Interventions

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Finerenone (BAY 94-8862) PEG solution

2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862

Intervention Type DRUG

Finerenone (BAY 94-8862) immediate release tablet

20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets

Intervention Type DRUG

Eplerenone (Inspra®)

Single oral dose of 50 mg eplerenone

Intervention Type DRUG

Placebo

Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

46 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Neuss, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Related Links

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http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

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2010-018500-90

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13786

Identifier Type: -

Identifier Source: org_study_id

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