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

NCT01579903 | Completed Phase 1

• 1 other identifier: B1831077
• Study Type: interventional
• Target: 16
• Locations: 3 countries
• Sites: 3

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.

Conditions

Hemophilia A

Keywords

Hemophilia A; moroctocog alfa (AF-CC); ReFacto AF; dual-chamber syringe; bioavailability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

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

Drug: moroctocog alfa (AF-CC)

Sequence 2

EXPERIMENTAL

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

Drug: moroctocog alfa (AF-CC)

Interventions

moroctocog alfa (AF-CC) DRUG

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

Sequence 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Pfizer Investigational Site

Sofia, 1612, Bulgaria

Location

Pfizer Investigational Site

Budapest, 1083, Hungary

Location

Pfizer Investigational Site

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

• Shafer F, Charnigo RJ, Plotka A, Baumann J, Liang Y, Korth-Bradley J. Assessment of relative bioavailability of two presentations of moroctocog alfa (AF-CC) in subjects with moderately severe or severe hemophilia A. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):237-41. doi: 10.1002/cpdd.168. Epub 2014 Oct 27.

  PMID: 27140804 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hemophilia A

Interventions

recombinant factor VIII SQ

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 18, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 8, 2013

Record last verified: 2013-02

Locations

BU (1); GB (1); HU (1)