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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

August 18, 2011
December 1, 2015
March 2010
November 2010   (final data collection date for primary outcome measure)
  • 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
Pharmacodynamics (natriuresis) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01473108 on ClinicalTrials.gov Archive Site
Number of participants with adverse events [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]
  • Adverse Event Collection [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters (maximum concentration [Cmax]) [ Time Frame: Up to 60 hours after administration ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters (area under the curve [AUC]) [ Time Frame: Up to 60 hours after administration ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862
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
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.
Clinical pharmacology
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Pharmacology, Clinical
  • Drug: Finerenone (BAY 94-8862) PEG solution
    2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862
  • 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 (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.
    Interventions:
    • Drug: Finerenone (BAY 94-8862) PEG solution
    • Drug: Eplerenone (Inspra®)
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Finerenone (BAY 94-8862) PEG solution
    • Drug: Eplerenone (Inspra®)
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Finerenone (BAY 94-8862) PEG solution
    • Drug: Eplerenone (Inspra®)
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Finerenone (BAY 94-8862) immediate release tablet
    • Drug: Eplerenone (Inspra®)
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Finerenone (BAY 94-8862) PEG solution
    • Drug: Eplerenone (Inspra®)
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
May 2011
November 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 46 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01473108
13786, 2010-018500-90
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP