diseases requiring anticoagulation
Conditions
Interventions
VMX-C001 in suspension for intravenous (i.v.) infusion
Apixaban 5 mg tablets or Edoxaban 60 mg tablets or Rivaroxaban 20 mg tablets.
5000 IU/mL heparin sodium for intravenous (i.v.) infusion
Sponsors
VarmX B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Men and women of any ethnic origin aged between 18 and 49 years of age, inclusive, at the time of Screening. 2. Male subjects must be willing to use appropriate contraception, such as a condom, and to refrain from sperm donation during the study and until 90 days after VMX-C001 administration. 3. Women of child-bearing potential must agree not to attempt to become pregnant and to use a highly effective form of birth control during the study and for 180 days after study drug administration when their sexual partner has not been vasectomized. Highly effective forms of birth control entail the use of combined (estrogen- and progestogen-containing) or progestogen-only hormonal contraception associated with inhibition of ovulation, an intrauterine device (IUD), an intrauterine hormone-releasing system (IUS) or abstinence. 4. Postmenopausal women must have had >=12 months of spontaneous amenorrhea (with documented follicle-stimulating hormone (FSH) >=30 mIU/mL).
Exclusion criteria
Exclusion criteria: 1. The subject has been administered VMX-C001 before. 2. The subject has taken piroxicam in the 2 weeks prior to Day 1. 3. The subject has taken any non-aspirin, non-piroxicam NSAID in the week prior to Day 1. 4. The subject requires or has taken during the month prior to Day 1, vitamin K for therapeutic reasons. Vitamin K not taken for therapeutic purposes is acceptable throughout the study, e.g. as part of a multivitamin supplement. 5. The subject is receiving or requires, for any cause, any anticoagulant or antiplatelet therapy including warfarin, clopidogrel or aspirin or any other anticoagulant or antiplatelet agent or has used these therapies in the month prior to Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PD parameters of VMX-C001 and the DOAC on the anticoagulant effect of unfractionated heparin: PT, aPTT, DRVVT, dPT, D-dimer, calibrated automated thrombography (thrombin generation), real time activated clotting time (ACT) recording, and DOAC concentration. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety and tolerability parameters include: physical examination, AEs, clinical laboratory values, vital signs, 12-lead electrocardiogram (ECG). • Immunogenicity: antibodies against VMX-C001 and human coagulation FX in plasma. | — |
Countries
Netherlands
Outcome results
None listed