Haemostasis, Healthy
Conditions
Brief summary
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a targeted INR (International Normalization Ratio).
Interventions
DRUGwarfarin
After a baseline punch biopsy (B0), warfarin is administered over a period of approximately 7-14 days. Dose is adjusted individually to achieve INR target. Once a stable INR is achieved, a second biopsy (B1) will be performed
DRUGeptacog alfa (activated)
If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration
DRUGplacebo
If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* INR below or equal to 1.2
Exclusion criteria
* The receipt of any investigational drug within 1 month prior to this trial * Use of anticoagulation therapy-defined as vitamin K antagonists, platelet antagonists, heparin (or low molecular weight heparin), aspirin or NSAIDs (Non-Steroidal Anti-Inflammatory Drug) within 14 days prior to trial * African-American race * Weight above 160 kg * Supplemental Vitamin K use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding duration measured in minutes after biopsies in trial part A | From onset of bleeding till the end of the bleeding |
| Bleeding duration measured in minutes after biopsy B1 in trial part B | From onset of bleeding till the end of the bleeding |
Secondary
| Measure | Time frame |
|---|---|
| Blood volume reported in millilitres after biopsies in trial part A | From onset of bleeding till the end of the bleeding |
| Blood volume reported in millilitres after biopsy B1 in trial part B | From onset of bleeding till the end of the bleeding |
| Adverse events, including thrombotic events | From day 0 to days 14-28 |
| Change in coagulation-related parameters after biopsy B1 | From baseline to 3 hours after B1 |
| Change in coagulation-related parameters after biopsy B2 | From baseline to 3 hours after B2 |
| Change in coagulation-related parameters after biopsy B3 | From baseline to 3 hours after B3 |
| Clot dynamics: R in minutes (trial part B) | Time to onset of clot formation |
| Clot dynamics: K in minutes (trial part B) | Time to achieve 20mm clot strength |
Countries
United States
Outcome results
None listed