Haemostasis, Healthy
Conditions
Brief summary
This trial is conducted in the United States of the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).
Interventions
DRUGeptacog alfa (activated)
If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies
DRUGclopidogrel
Following a baseline biopsy (B0) subjects will receive oral treatment with an initial 300 mg loading dose followed by daily 75 mg doses for at least 3 additional days. If the target platelet inhibition (PI) is achieved, the subject will undergo punch biopsy 1 (B1).
DRUGplacebo
If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies
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 45 Years
Healthy volunteers
No
Inclusion criteria
* PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0) * Platelet count within normal laboratory range
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 30 days prior to trial * African-American race * Weight above or equal to 160 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding duration measured in minutes | From onset of bleeding till the end of the bleeding |
Secondary
| Measure | Time frame |
|---|---|
| Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes | Time to onset of clot formation |
| Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes | Time to achieve 20 mm clot strength |
| Adverse events, including thrombotic events | From screening to day 11-18 |
| Blood volume reported in millilitres | From onset of bleeding till the end of the bleeding |
| 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 1 hour after B3 |
| Change in coagulation-related parameters after pre-biopsy | From baseline to 15 minutes after pre-biopsy |
Countries
United States
Outcome results
None listed