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OpenTrials
Completed

NCT Number: NCT01473108

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

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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Key information

Conditions

Clinical Pharmacology

Age range

18 year–46 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, North Rhine-Westphalia, 41460, Germany

About this study

Clinical pharmacology

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Finerenone (BAY 94-8862) PEG solution

Drug

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

Finerenone (BAY 94-8862) immediate release tablet

Drug

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

Eplerenone (Inspra®)

Drug

Single oral dose of 50 mg eplerenone

Placebo

Drug

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

Primary outcomes

  1. Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis)

    Time frame: Up to 26 hours post-dose

  2. AUC (Area under the concentration vs time curve from zero to infinity after single (first) dose for both BAY 94-8862 and eplerenone)

    Time frame: Up to 60 hours after administration

  3. Cmax (Maximum observed drug concentration in measured matrix after single dose administration for both BAY 94-8862 and eplerenone)

    Time frame: Up to 60 hours after administration

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: Up to 28 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Study to Investigate the Effectiveness of Different Single Oral Doses of BAY94-8862 on Natriuresis After Administration of 0.5 mg Fludrocortisone (Astonin H®) With 50 mg Eplerenone (Inspra®) as Active Control in Healthy Male Subjects in a Randomized, Single-blind, Placebo-controlled, Combined 3-fold Crossover and Parallel-group Design

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Nov 17, 2011
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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