Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: BAY94-8862 + Placebo + Eplerenone (Drug); BAY94-8862 + Placebo + Eplerenone (Drug); BAY94-8862 + Placebo + Eplerenone (Drug); BAY94-8862 + Placebo + Eplerenone (Drug); BAY94-8862 + Placebo + Eplerenone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)
Primary outcome: Pharmacodynamics (natriuresis)
Secondary outcome: Adverse Event CollectionPharmacokinetic parameters (maximum concentration [Cmax]) Pharmacokinetic parameters (area under the curve [AUC])
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Healthy male white subjects
- 18 to 45 years of age
- Body mass index (BMI): 18 - 29. 9 kg/mĀ²
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
Locations and Contacts
Neuss, Nordrhein-Westfalen 41460, Germany
Additional Information
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Starting date: March 2010
Last updated: December 10, 2013
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