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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hemophilia A

Treatments: Drug: moroctocog alfa (AF-CC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01579903

B1831077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

16 participants in 2 patient groups

Sequence 1

Experimental group

Description:

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

Treatment:

Drug: moroctocog alfa (AF-CC)

Drug: moroctocog alfa (AF-CC)

Sequence 2

Experimental group

Description:

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

Treatment:

Drug: moroctocog alfa (AF-CC)

Drug: moroctocog alfa (AF-CC)