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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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%)

Conditions
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Hemophilia A

Intervention / Treatment
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* Drug: moroctocog alfa (AF-CC)
* Drug: moroctocog alfa (AF-CC)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2. | Drug: moroctocog alfa (AF-CC)<br>* Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent); Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes<br>|
| Experimental: Sequence 2<br>Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2. | Drug: moroctocog alfa (AF-CC)<br>* Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes; Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (secondary PK parameters include: tmax, λz, t1/2, CL, Vss, and FVIII Recovery) |  | Periods 1 and 2, Day 1 through Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemophilia A, moroctocog alfa (AF-CC), ReFacto AF, dual-chamber syringe, bioavailability