Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)

An Open-Label, Randomized, Two-period Crossover Study To Compare Relative Bioavailability of Two Formulations of Moroctocog Alfa (Af-cc) In Subjects With Moderately Severe Or Severe Hemophilia A (FVIII:C </=2%)

This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when administered as 2 different dose presentations. The first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.

This study is being conducted in order to satisfy a post-approval EMA commitment to compare the pharmacokinetics of the 2 dose presentations used in this study.

Inclusion Criteria:

• Male patients at least 18 years old with severe or moderately severe hemophilia A (facto VIII concentration less than or equal to 2%).
• Negative test for facto VIII inhibitor.
• If applicable, HIV or hepatitis treatment is stable at the time of enrollment.
• Ability to abstain from use of FVIII products for 72 hours at a time.

Exclusion Criteria:

• History of any positive test result for factor VIII inhibitor.
• Presence of any bleeding disorder in addition to Hemophilia A.
• Body weight less than 50 kg.
• History of alcoholism.
• Treatment with investigational drug or device within 30 days prior to the Screening visit.