Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Randomized, Placebo-controlled Single-dose, Double-blind Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847989
• Other study ID #: F13-1661
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2013
• Last updated: January 10, 2017
• Start date: January 2003
• Est. completion date: May 2003

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Normal platelet count and clotting parameters

• Adequate renal and hepatic function

• If female and of child-bearing potential, negative serum pregnancy test within 21 days of enrollment and a negative urine pregnancy test on admission to the clinical research unit

• If a sexually active male or a sexually active female of child-bearing potential,agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits

• Negative drug and alcohol screens

Exclusion Criteria:

• Known antibodies or hypersensitivity to FXIII

• Known bleeding or hematologic disorder

• Known allergy to yeast

• Receipt of blood products within 30 days of screening

• Donation of blood within 30 days prior to enrollment

• Any surgical procedure in the 30 days prior to enrollment

• Previous history of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus

• Receipt of treatment with any experimental agent within 30 days of study enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Congenital FXIII Deficiency
• Healthy
• Hemostatic Disorders

Intervention

Drug:
• catridecacog
Single doses of rFXIII administered intravenously (IV) to eight subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).
• placebo
Single doses of placebo administered intravenously (IV) to two subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Reynolds TC, Butine MD, Gunewardena KA, MacMahon M, Zuckerman LA, Bishop LA, Morton KM. A randomized, double-blind, placebo-controlled study of the safety and pharmacokinetics of a single dose of recombinant factor XIII in healthy volunteers. Journal of T

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Days 0-28	No
Secondary	Incidence of clinically significant changes from baseline in physical examination or laboratory measurements		Days 0-28	No
Secondary	Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)		Days 0-28	No
Secondary	Incidence of yeast antibodies		Days 0-28	No

External Links

•   Clinical Trials at Novo Nordisk