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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01579903

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemophilia A	Drug: moroctocog alfa (AF-CC) Drug: moroctocog alfa (AF-CC)	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

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%)

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2.	Drug: moroctocog alfa (AF-CC) 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
Experimental: Sequence 2 Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2.	Drug: moroctocog alfa (AF-CC) 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)

Arm

Intervention/Treatment

Experimental: Sequence 1

Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2.

Drug: moroctocog alfa (AF-CC)

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

Experimental: Sequence 2

Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2.

Drug: moroctocog alfa (AF-CC)

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)

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.