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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:
Bayer
ClinicalTrials.gov Identifier:
NCT01473108
First received: August 18, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes

August 18, 2011
December 6, 2012
March 2010
November 2010   (final data collection date for primary outcome measure)
Pharmacodynamics (natriuresis) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01473108 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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

Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Heart Failure
  • Drug: BAY94-8862 + Placebo + Eplerenone
    3fold crossover of single dose 20 mg BAY94-8862 solution, placebo and 50 mg eplerenone
  • Drug: BAY94-8862 + Placebo + Eplerenone
    3fold crossover of single dose 10 mg BAY94-8862 solution, placebo and 50 mg eplerenone
  • Drug: BAY94-8862 + Placebo + Eplerenone
    3fold crossover of single dose 5 mg BAY94-8862 solution, placebo and 50 mg eplerenone
  • Drug: BAY94-8862 + Placebo + Eplerenone
    3fold crossover of single dose 20 mg BAY94-8862 tablets, placebo and 50 mg eplerenone
  • Drug: BAY94-8862 + Placebo + Eplerenone
    3fold crossover of single dose 2.5 mg BAY94-8862 solution, placebo and 50 mg eplerenone
  • Experimental: Arm 1
    Intervention: Drug: BAY94-8862 + Placebo + Eplerenone
  • Experimental: Arm 2
    Intervention: Drug: BAY94-8862 + Placebo + Eplerenone
  • Experimental: Arm 3
    Intervention: Drug: BAY94-8862 + Placebo + Eplerenone
  • Experimental: Arm 4
    Intervention: Drug: BAY94-8862 + Placebo + Eplerenone
  • Experimental: Arm 5
    Intervention: Drug: BAY94-8862 + Placebo + Eplerenone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male white subjects
  • 18 to 45 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 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01473108
13786, 2010-018500-90
No
Head Clinical Pharmacology, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2012

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