Brief Title
Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)
Official Title
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%)
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (primary PK parameters include: Cmax, AUClast, and AUCinf)
Secondary Outcome
Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (secondary PK parameters include: tmax, λz, t1/2, CL, Vss, and FVIII Recovery)
Condition
Hemophilia A
Intervention
moroctocog alfa (AF-CC)
Study Arms / Comparison Groups
Sequence 1
Description: Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
16
Start Date
August 2012
Completion Date
January 2013
Primary Completion Date
January 2013
Eligibility Criteria
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.
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT01579903
Organization ID
B1831077
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
February 2013