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NCT01473108 Clinical Trial

Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862

Clinical Pharmacology Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01473108
Other study ID # 13786
Secondary ID 2010-018500-90
Status Completed
Phase Phase 1
First received
Last updated
Start date March 29, 2010
Est. completion date May 17, 2011

Study information
Verified date January 2022
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

Clinical pharmacology

Recruitment information / eligibility
Status Completed
Enrollment 67
Est. completion date May 17, 2011
Est. primary completion date November 30, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 46 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Finerenone (BAY 94-8862) PEG solution
2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862
• Finerenone (BAY 94-8862) immediate release tablet
20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets
• Eplerenone (Inspra®)
Single oral dose of 50 mg eplerenone
• Placebo
Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis) Up to 26 hours post-dose
Primary AUC (Area under the concentration vs time curve from zero to infinity after single (first) dose for both BAY 94-8862 and eplerenone) Up to 60 hours after administration
Primary Cmax (Maximum observed drug concentration in measured matrix after single dose administration for both BAY 94-8862 and eplerenone) Up to 60 hours after administration
Secondary Number of participants with adverse events Up to 28 days
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