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%)

NCT01579903 Phase 1 COMPLETED

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.

Details

Lead sponsor	Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	16
Start date	2012-08
Completion	2013-01

Conditions

• Hemophilia A

Interventions

• moroctocog alfa (AF-CC)
• moroctocog alfa (AF-CC)

Primary outcomes

• Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (primary PK parameters include: Cmax, AUClast, and AUCinf) — Periods 1 and 2, Day 1 through 4

Countries

Bulgaria, Hungary, United Kingdom