Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.
Interventions
DRUGactivated recombinant human factor VII
All subjects will receive one i.v. (intravenous, into the vein) injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week.
DRUGeptacog alfa (activated)
All subjects will receive one i.v. injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male, age 18-55 years, both inclusive, at the time of signing informed consent * Body Mass Index (BMI) 18.5-30 kg/m\^2, both inclusive * Good general health based on assessment of medical history, vital signs, physical examination, ECG (electrocardiogram), and laboratory data at screening, as judged by the investigator
Exclusion criteria
* Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve | After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose |
| Maximum concentration | After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse events (including serious adverse events) | Assessed up to 7 weeks following first trial product administration |
| Incidence of antibodies | Assessed up to 7 weeks following first trial product administration |
Outcome results
None listed