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

Phase 1

Completed

• Conditions: Hemophilia A
• Interventions: Drug: moroctocog alfa (AF-CC)

• Registration Number: NCT01579903
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Study Start: 2012-08
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	moroctocog alfa (AF-CC)	Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2.
Sequence 1	moroctocog alfa (AF-CC)	Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 London, United Kingdom