Acquired Bleeding Disorder, Acquired Haemophilia, Congenital Bleeding Disorder, Congenital FVII Deficiency, Glanzmann's Disease, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).
Interventions
DRUGactivated recombinant human factor VII
One single dose administration, injected i.v. (into the vein)
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 45 Years
Healthy volunteers
No
Inclusion criteria
* Caucasian * Body Mass Index (BMI) between 18 and 27 kg/m\^2, both inclusive * Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results * Smoke less than 10 cigarettes (or equivalent) per day * Capable of giving written Informed Consent (IC)
Exclusion criteria
* Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator * Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I * Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation * Overt bleeding, including from gastrointestinal tract * Hepatitis (B or C) infection * HIV (human immunodeficiency virus) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve for FVIIa clot activity | — |
Secondary
| Measure | Time frame |
|---|---|
| The maximum plasma concentration (Cmax) | — |
| Terminal half-life (t½) | — |
Countries
France
Outcome results
None listed