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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Congenital Bleeding Disorder, Congenital FXIII Deficiency, Healthy

Intervention / Treatment
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* Drug: catridecacog
* Drug: recombinant factor XIII


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial part 1<br> | Drug: catridecacog<br>* 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.<br>|
| Experimental: Trial part 2<br> | Drug: recombinant factor XIII<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (serious and non-serious) |  | over 8 weeks of treatment |