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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
  Purpose

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.


Condition Intervention Phase
Heart Failure
 Drug: BAY94-8862 + Placebo + Eplerenone
 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:

MedlinePlus related topics: Heart Failure
Drug Information available for: Eplerenone
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacodynamics (natriuresis) [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 67
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY94-8862 + Placebo + Eplerenone
3fold crossover of single dose 20 mg BAY94-8862 solution, placebo and 50 mg eplerenone
Experimental: Arm 2 Drug: BAY94-8862 + Placebo + Eplerenone
3fold crossover of single dose 10 mg BAY94-8862 solution, placebo and 50 mg eplerenone
Experimental: Arm 3 Drug: BAY94-8862 + Placebo + Eplerenone
3fold crossover of single dose 5 mg BAY94-8862 solution, placebo and 50 mg eplerenone
Experimental: Arm 4 Drug: BAY94-8862 + Placebo + Eplerenone
3fold crossover of single dose 20 mg BAY94-8862 tablets, placebo and 50 mg eplerenone
Experimental: Arm 5 Drug: BAY94-8862 + Placebo + Eplerenone
3fold crossover of single dose 2.5 mg BAY94-8862 solution, placebo and 50 mg eplerenone

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01473108     History of Changes
Other Study ID Numbers: 13786, 2010-018500-90
Study First Received: August 18, 2011
Last Updated: December 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
CHF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Eplerenone
Aldosterone Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013