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.
Clinical pharmacology
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
67
2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862
20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets
Single oral dose of 50 mg eplerenone
Unnamed facility
Neuss, North Rhine-Westphalia, Germany
Log10 (10*urinary Na+/K+ ratio) (Parameter for natriuresis)
Time frame: Up to 26 hours post-dose
AUC (Area under the concentration vs time curve from zero to infinity after single (first) dose for both BAY 94-8862 and eplerenone)
Time frame: Up to 60 hours after administration
Cmax (Maximum observed drug concentration in measured matrix after single dose administration for both BAY 94-8862 and eplerenone)
Time frame: Up to 60 hours after administration
Number of participants with adverse events
Time frame: Up to 28 days
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Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step