Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin (NCT06517563) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin
Netherlands16 participantsStarted 2024-08-14
Plain-language summary
A single centre, open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin (UFH) and of VMX-C001 alone on the efficacy of Low Molecular Weight Heparin (LMWH) in healthy subjects conducted in two parts:
UFH cohort: Subjects will be administered 2 single doses of 5000 IU UFH i.v. on Day 1 and Day 5, oral doses of the DOAC Rivaroxaban once daily from Day 2 until the morning of Day 5, and one single dose of 170 mg VMX-C001 i.v. on Day 5.
LMWH cohort: Subjects will be administered 2 single doses of 40 mg Enoxaparin s.c. on Day 1 and Day 4, and one single dose of 170 mg VMX-C001 i.v. on Day 4.
Who can participate
Age range18 Years – 49 Years
SexALL
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Inclusion criteria
✓. Men and women of any ethnic origin aged between 18 and 49 years of age, inclusive, at the time of Screening.
✓. Male subjects must be willing to use appropriate contraception, such as a condom, and to refrain from sperm donation during the main study and until 90 days after study drug administration.
✓. 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 main study and for 90 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.
✓. Postmenopausal women must have had ≥12 months of spontaneous amenorrhea (with documented follicle stimulating hormone \[FSH\] \>33.4 IU/L).
✓. Surgically sterile women are defined as those who have had a surgical bilateral oophorectomy with or without hysterectomy, total hysterectomy or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, the reproductive status of the woman has to be confirmed by follow-up hormone level assessment. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
✓. Subject must weigh between 60 and 120 kg, inclusive, and must have a BMI between 18.0 and 30.0 kg/m2, inclusive, at Screening and on Day -1.
What they're measuring
1
Change in thrombin time following dosing with VMX-C001(UFH cohort)
Timeframe: Up to Day 6
2
Change in prothrombin time (PT) following dosing with VMX-C001
Timeframe: Up to End of Study (Day 32/33)
3
Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001
Timeframe: Up to End of Study (Day 32/33)
4
Change in fibrinogen following dosing with VMX-C001
Timeframe: Up to End of Study (Day 32/33)
5
Change in dilute Russell viper venom time (dRVVT) following dosing with VMX-C001(UFH Cohort only)
Timeframe: Up to Day 6
6
Change in dilute prothrombin time (dPT) following dosing with VMX-C001 (UFH Cohort only)
Timeframe: Up to Day 6
7
Change in thrombin generation following dosing with VMX-C001
Timeframe: Up to Day 6
8
Change in real time activated clotting time (ACT) following dosing with VMX-C001 (UFH cohort only)
✓. Subject must be in good health, as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations (congenital non hemolytic hyperbilirubinemia is acceptable).
✓. Subject is willing and able to give their written informed consent to participate in the study and to abide by the study restrictions.
Exclusion criteria
✕. The subject has taken tenoxicam in the 35 days prior to Day 1 or has taken piroxicam in the two weeks prior to Day 1.
✕. 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 4 weeks prior to Day 1.
✕. The subject has taken any non-aspirin, non-tenoxicam, non-piroxicam non-steroidal antiinflammatory drug (NSAID) in the week prior to Day 1.
✕. The subject requires or has taken during the 4 weeks prior to Day 1, vitamin K for therapeutic reasons. Vitamin K not taken for therapeutic purposes is acceptable, e.g. as part of a multivitamin supplement.
✕. The subject has received any prescribed oral, systemic or topical medication, including any vaccinations, within 14 days before Day 1 (with the exception of contraceptives), unless in the opinion of the Principal Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
✕. The subject has used any non-prescribed systemic or topical medication (including herbal remedies) within 4 days prior to Day 1 (with the exception of oral vitamin/mineral supplements \[including those that contain vitamin K when not taken for therapeutic purposes\] and paracetamol), unless in the opinion of the Principal Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
✕. The subject has been administered an investigational drug (new chemical or biological entity) within 4 weeks prior to Day 1 for small molecules or within 12 weeks or 5 halflives, whichever is longer, prior to Day 1 for all other types of investigational drug.
✕. The subject has donated ≥500 mL blood, plasma or platelets in the 12 weeks prior to Screening or the subject has donated any blood amount within 30 days prior to Screening.
Timeframe: Up to Day 6
9
Change in anti-factor 10a (FXa) activity following dosing with VMX-C001 (LMWH Cohort only)