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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 Collection

Pharmacokinetic 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

Page last updated: August 23, 2015

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