Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects

Healthy Clinical Trial

Official title:

A Single Centre, Randomised, Double-blind, Cross-over Trial in Healthy Male Subjects Investigating Bioequivalence and Pharmacokinetics of rFXIII (Avecia DS) to rFXIII (Novo Nordisk DS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082406
• Other study ID #: NN1841-3788
• Secondary ID: 2009-016438-28U1
• Status: Completed
• Phase: Phase 1
• First received: March 5, 2010
• Last updated: September 20, 2016
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: September 2016
• 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 is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) between 18.5 and 30 kg/m2

• Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram), and clinical laboratory data at screening, as judged by the physician

• Non-smokers

Exclusion Criteria:

• Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the physician

• Blood transfusion within 3 months of trial start

• Positive for hepatitis B or C infection

• Positive for Human Immunodeficiency Virus (HIV) infection

• Excessive consumption of a diet deviating from a normal diet as judged by the physician

• Blood or plasma donation within the last 3 months prior to trial start

• Subjects with any history of migraine

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover 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 dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) administered iv.
• recombinant factor XIII
Single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) to be administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv.

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration-time curve (Area under Curve 0-28 days) for factor XIII activityfor both drug substances measured by the Berichrom® assay		after 4 weeks of treatment	No
Secondary	Number of adverse events (serious and non-serious)		over 8 weeks of treatment	Yes

External Links

•   Clinical Trials at Novo Nordisk