The primary objective of this study is to assess the pharmacokinetics in patients with severe hemophilia. The secondary objective is to assess the pharmacodynamics of BAY1093884 based on tissue factor pathway inhibitor activity
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
0.3 mg/kg given intravenously
1 mg/kg given intravenously
Chaim Sheba Medical Center
Ramat Gan, Israel
AUC (0-tlast) of BAY1093884 in plasma
Area under the concentration vs. time curve from time 0 to the last data point \> LLOQ
Time frame: Up to 15 days after drug administration
AUC(0-tlast)/D of BAY1093884 in plasma
AUC(0-tlast) divided by dose
Time frame: Up to 15 days after drug administration
Cmax of BAY1093884 in plasma
Maximum observed drug concentration in measured matrix after single dose administration
Time frame: Up to 15 days after drug administration
Cmax/D of BAY1093884 in plasma
Cmax divided by dose
Time frame: Up to 15 days after drug administration
Tissue factor plasma inhibitor activity: effect of BAY1093884 to inhibit the anticoagulatory activity of plasma TFPI as assessed by a chromogenic assay
Time frame: Up to 15 days after drug administration
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