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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01473108
First received: August 18, 2011
Last updated: December 1, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Pharmacology, Clinical
Drug: Finerenone (BAY 94-8862) PEG solution
Drug: Finerenone (BAY 94-8862) immediate release tablet
Drug: Eplerenone (Inspra®)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Log10 (10*urinary Na+/K+ ratio) [ Time Frame: Up to 26 hours post-dose ] [ Designated as safety issue: No ]
    Parameter for natriuresis

  • AUC [ Time Frame: Up to 60 hours after administration ] [ Designated as safety issue: No ]
    Area under the concentration vs time curve from zero to infinity after single (first) dose for both BAY 94-8862 and eplerenone

  • Cmax [ Time Frame: Up to 60 hours after administration ] [ Designated as safety issue: No ]
    Maximum observed drug concentration in measured matrix after single dose administration for both BAY 94-8862 and eplerenone


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: March 2010
Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Finerenone (BAY 94-8862) PEG solution
2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862
Drug: Eplerenone (Inspra®)
Single oral dose of 50 mg eplerenone
Drug: Placebo
Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step
Experimental: 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.
Drug: Finerenone (BAY 94-8862) PEG solution
2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862
Drug: Eplerenone (Inspra®)
Single oral dose of 50 mg eplerenone
Drug: Placebo
Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step
Experimental: 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.
Drug: Finerenone (BAY 94-8862) PEG solution
2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862
Drug: Eplerenone (Inspra®)
Single oral dose of 50 mg eplerenone
Drug: Placebo
Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step
Experimental: 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.
Drug: Finerenone (BAY 94-8862) immediate release tablet
20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets
Drug: Eplerenone (Inspra®)
Single oral dose of 50 mg eplerenone
Drug: Placebo
Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step
Experimental: 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.
Drug: Finerenone (BAY 94-8862) PEG solution
2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862
Drug: Eplerenone (Inspra®)
Single oral dose of 50 mg eplerenone
Drug: Placebo
Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

Detailed Description:
Clinical pharmacology
  Eligibility

Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473108

Locations
Germany
Neuss, Nordrhein-Westfalen, Germany, 41460
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01473108     History of Changes
Other Study ID Numbers: 13786  2010-018500-90 
Study First Received: August 18, 2011
Last Updated: December 1, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Healthy volunteers, proof-of-concept trial, PK and PD

Additional relevant MeSH terms:
Pharmaceutical Solutions
Fludrocortisone
Eplerenone
Spironolactone
Anti-Inflammatory Agents
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on July 27, 2016