BAY94-9027 PK Study Comparing to Another Long Acting Product

Single Dose, Open Label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94 9027 and Elocta

The purpose of this study is to compare the pharmacokinetics of BAY94-9027 and Elocta after intravenous administration.

Inclusion Criteria:

• Males, age 18 to 65 years.
• Subjects with Severe Hemophilia A with a documented plasma FVIII level of < 1%
• ≥ 150 exposure days with FVIII concentrate(s) as supported by medical records

Exclusion Criteria:

• Evidence of current or past inhibitor antibody:
• History of any congenital or acquired coagulation disorders other than hemophilia A.
• Platelet count <75,000/mm*3.
• Abnormal renal function (serum creatinine >2 x the upper limit of the normal range).
• Active liver disease verified by medical history or persistently elevated alanine aminotransferase or aspartate aminotransferase >5 x the upper limit of the normal range or severe liver disease as evidenced by, but not limited to any of the following: International Normalized Ratio >1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.