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

February 7, 2013 updated by: Pfizer

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%)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1612
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1083
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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
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)
EXPERIMENTAL: Sequence 2
Subjects randomized to receive Treatment B 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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (primary PK parameters include: Cmax, AUClast, and AUCinf)
Time Frame: Periods 1 and 2, Day 1 through 4
Periods 1 and 2, Day 1 through 4

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: Periods 1 and 2, Day 1 through Day 4
Periods 1 and 2, Day 1 through Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (ESTIMATE)

April 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1831077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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