Coagulation DisorderPhase 1NCT05152420
Study of Intravenous VMX-C001 in Healthy Subjects and in Combination With Selected Direct Oral Anticoagulants in Healthy Older Subjects
A Phase 1 study testing VMX-C001, Apixaban and Rivaroxaban in people with Coagulation Disorder, run by VarmX B.V. at 1 site in Netherlands.
Trial summary
A single centre, double-blind, randomized, parallel group, placebo-controlled study in healthy subjects conducted in two parts: Part 1: Single ascending doses in healthy subjects aged 18 to 49 years to assess safety, pharmacokinetics (PK) and pharmacodynamic (PD) effects of VMX-C001. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Coagulation Disorder
- What is being tested?
- VMX-C001, Apixaban and Rivaroxaban
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Oct 2021to 3 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In Part 1, men and women of any ethnic origin aged between 18 and 49 years of age, inclusive, at the time of Screening.
- In Part 2, men and women of any ethnic origin aged between 50 and 79 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 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 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) ≥30 milli-International units (mIU)/mL).
- 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.
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- All women must have a negative pregnancy test result at Screening and on Day -1.
- Subject must weigh between 60 and 120 kg, inclusive, and must have a BMI between 18.0 and 30.0 kg/m^2, inclusive, at Screening and on Day -1.
- 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).
- Participant is willing and able to give their written informed consent to participate in the study and to abide by the study restrictions.
- Participant has good upper limb venous access.
Who cannot join
- The participant has taken piroxicam in the two weeks prior to the first administration of study drug or DOAC.
- The participant has taken any non-aspirin non-piroxicam NSAID in the week prior to the first administration of study drug or DOAC.
- The participant requires or has taken during the month prior to first administration of study drug or DOAC, vitamin K for therapeutic reasons. Vitamin K not taken for therapeutic purposes is acceptable, e.g. as part of a multivitamin supplement.
- The participant 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 the first administration of study drug or DOAC.
- The participant has received any prescribed oral, systemic or topical medication, including coronavirus disease (COVID)-19 vaccination, within 14 days prior to the first administration of study drug or DOAC (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 participant has used any non-prescribed systemic or topical medication (including herbal remedies) within one week prior to the first administration of study drug or DOAC (with the exception of oral vitamin/mineral supplements (that do not contain vitamin k) 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.
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- The participant is currently participating in a clinical study, e.g. attending follow-up visits or has been administered an investigational drug (new chemical or biological entity) in the 3 months prior to administration of the study drug.
- The participant has donated >500 mL blood, plasma or platelets in the 3 months prior to Screening.
- Because of an increased risk of thrombosis participants with known diabetes mellitus or a fasted glucose ≥7.0 mmol/l at Screening.
- The participant has any bleeding diathesis, any increased risk of bleeding or, in the opinion of the Principal Investigator, is at increased risk of the consequences of bleeding including but not limited to the following:
- gastro-intestinal ulceration within the last 3 months
- known or suspected oesophageal varices.
- vascular aneurysms or known arteriovenous malformations;
- history of known major intraspinal or intracerebral vascular abnormalities.
- history of brain, spinal or ophthalmic surgery within the last year.
- any intracranial hemorrhage.
- uncontrolled severe hypertension.
- The participant has, in the opinion of the Principal Investigator, any increased risk of thrombosis or thromboembolism including any known thrombophilia, such as antiphospholipid syndrome, or any past history of thrombosis.
- The participant has a significant history of drug allergy, as determined by the Principal Investigator.
- The participant has, at Screening or on Day -1, a supine blood pressure or supine pulse rate ≥ 150/95 mmHg and 100 beats per minute (bpm), respectively, or < 90/40 mmHg and 40 bpm, respectively, confirmed by a repeat assessment.
- The participant consumes >21 alcoholic drinks/week for men or >14 alcoholic drinks/week for women (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1 measure [25 mL] of spirits), or has a significant history of alcoholism or drug/chemical abuse, as determined by the Principal Investigator for Part 1. For Part 2, the participant consumes >7 alcoholic drinks/week.
- The participant has a positive urine drug screen, alcohol breath test or cotinine test results at Screening or on Day -1, confirmed by repeat testing.
- The female participant has a positive pregnancy test at Screening or on Day -1 or is lactating.
- The participant currently smokes or uses nicotine-containing products. Former smokers will be eligible, provided participants have not smoked for at least 3 months prior to administration of the study drug.
- The participant has, or has a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, hematological or other major disorders, as determined by the Principal Investigator.
- The participant has a positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody test result at Screening.
- The participant has an abnormality in the 12-lead ECG at Screening or on Day -1 that, in the judgement of the Principal Investigator may, during the study, interfere with the interpretation of 12-lead ECG results, including average QTcF interval >450 msec for men or >470 msec for women, 2nd or 3rd degree atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolff-Parkinson-White Syndrome, defined as average PR<110 msec, confirmed by a triplicate repeat ECG.
- The participant has any other condition that, in the opinion of the Principal Investigator, would compromise the safety of the participant or the participant's ability to comply with the protocol and complete the study.
- The participant has renal insufficiency (serum creatinine level > 1.25 times upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) of ≤60 mL/minute).
- The participant has active liver disease (ALT/ aspartate aminotransferase (AST) >1.5x ULN, total bilirubin > 1.5x ULN at Screening or on Day -1. One re-test is allowed).
- Additional exclusion criteria for Part 2 only:
- Because of an effect on DOACs,participants are to be excluded if he/she receives or has received medication that is an inhibitor of P-glycoprotein or CYP3A4. (eg clarithromycin, erythromycin and azole-antimycotics such as ketoconazole, itraconazole, voriconazole and osaconazole or HIV protease inhibitors.) within 30 days prior to first administration of DOAC.
- Because of an effect on DOACs, participants are to be excluded if he/she receives or has received treatment with CYP3A4 inducers (eg St. John's wort, rifampicin, phenytoin, carbamazepine, phenobarbital within 30 days prior to first administration of DOAC.
- Because of an effect on DOACs, participants are to be excluded if he/she receives or has received treatment with selective serotonin reuptake inhibitors (SSRIs) or selective noradrenaline reuptake inhibitors (SNRIs) within 30 days prior to first administration of DOAC.
- The participant has any contra-indication to treatment with DOACs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered VMX-C001 in Healthy Subjects (Part 1) and in Combination With Selected Direct Oral Anticoagulants (DOACs) in Healthy Older Subjects (Part 2)
A single centre, double-blind, randomized, parallel group, placebo-controlled study in healthy subjects conducted in two parts:
Part 1: Single ascending doses in healthy subjects aged 18 to 49 years to assess safety, pharmacokinetics (PK) and pharmacodynamic (PD) effects of VMX-C001.
Part 2: Healthy subjects aged 50 to 79 years to assess safety, PK and PD effects of VMX-C001 in the presence of DOACs.
- Conditions
- Coagulation Disorder
- Being tested
- VMX-C001, Placebo, Apixaban, Rivaroxaban, Edoxaban
- Keywords
- Direct oral anticoagulant (DOAC), Human coagulation factor X
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMX-C001Drug
VMX-C001 is human factor X engineered to be insensitive to factor Xa DOACs
PlaceboDrug
VMX-C001 matched placebo
ApixabanDrug
FXa Inhibitor
RivaroxabanDrug
FXa Inhibitor
EdoxabanDrug
FXa Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Cohort 1 | Experimental | Single dose cohort Receives: Drug: VMX-C001; Drug: Placebo |
| Part 1 - Cohort 2 | Experimental | Single dose cohort Receives: Drug: VMX-C001; Drug: Placebo |
| Part 1 - Cohort 3 | Experimental | Single dose cohort Receives: Drug: VMX-C001; Drug: Placebo |
| Part 1 - Cohort 4 | Experimental | Single dose cohort Receives: Drug: VMX-C001; Drug: Placebo |
| Part 1 - Cohort 5 | Experimental | Single dose cohort Receives: Drug: VMX-C001; Drug: Placebo |
| Part 1 - Cohort 6 | Experimental | Single dose cohort Receives: Drug: VMX-C001; Drug: Placebo |
| Part 2 - Cohort 1 | Experimental | Single dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 Receives: Drug: VMX-C001; Drug: Placebo; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban |
| Part 2 - Cohort 2 | Experimental | Single dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 Receives: Drug: VMX-C001; Drug: Placebo; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban |
| Part 2 - Cohort 3 | Experimental | Single dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 Receives: Drug: VMX-C001; Drug: Placebo; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban |
| Part 2 - Cohort 4 | Experimental | Single dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 Receives: Drug: VMX-C001; Drug: Placebo; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban |
| Part 2 - Cohort 5 | Experimental | Single dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 Receives: Drug: VMX-C001; Drug: Placebo; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban |
| Part 2 - Cohort 6 | Experimental | Single dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 Receives: Drug: VMX-C001; Drug: Placebo; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban |
| Part 2 - Cohort 7 | Experimental | Single dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 Receives: Drug: VMX-C001; Drug: Placebo; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1)
Number of Subjects with One or More Drug Related Adverse Events (AEs) or any Serious AEs
Measured: Up to Day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 2)
Number of Subjects with One or More Drug Related Adverse Events (AEs) or any Serious AEs
Measured: Up to Day 31
PK of VMX-C001 in plasma after single dose administration - Cmax (Part 1)
Maximal concentration
Measured: Up to Day 7
PK of VMX-C001 in plasma after single dose administration - tmax (Part 1)
Time of maximal concentration
Measured: Up to Day 7
PK of VMX-C001 in plasma after single dose administration - t1/2 (Part 1)
Terminal elimination half-life
Measured: Up to Day 7
PK of VMX-C001 in plasma after single dose administration - AUC0-last (Part 1)
Area under the concentration-time curve from time of dosing to last measurable concentration
Measured: Up to Day 7
PK of VMX-C001 in plasma after single dose administration - AUC0-inf (Part 1)
Area under the concentration-time curve from time of dosing extrapolated to infinity
Measured: Up to Day 7
PK of VMX-C001 in plasma after single dose administration - Lambda z (Part 1)
Terminal elimination rate constant
Measured: Up to Day 7
PK of VMX-C001 in plasma after single dose administration - CL (Part 1)
Total body clearance
Measured: Up to Day 7
PK of VMX-C001 in plasma after single dose administration - Dose proportionality (Part 1)
Measured: Up to Day 7
Change in D-dimer, Thrombin-Antithrrombin complexes and prothrombin fragments F1 and F2 following dosing with VMX-C001 (Part 1 and Part 2)
Measured: Up to Day 28 post dose with VMX-C001
Change from baseline in thrombin generation (ETP) following dosing with VMX-C001 in subjects previously dosed with DOAC anticoagulants (Part 2)
Measured: Up to 24 hours post dose with VMX-C001
DOAC plasma concentrations (Part 2)
Measured: Up to Day 5
Secondary outcomes (4)
Antibodies against VMX-C001 in plasma (Part 1)
Immunogenicity
Measured: Up to Day 28
Antibodies against VMX-C001 in plasma (Part 2)
Immunogenicity
Measured: Up to Day 31
Antibodies against human coagulation FX in plasma (Part 1)
Immunogenicity
Measured: Up to Day 28
Antibodies against human coagulation FX in plasma (Part 2)
Immunogenicity
Measured: Up to Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start29 Oct 2021
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled, single ascending dose.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- VarmX B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152420
- Sponsor's protocol ID
- VMX-C001-01
- Status last verified
- Jun 2023
- First submitted
- 17 Nov 2021
- Last updated
- 2 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered VMX-C001 in Healthy Subjects (Part 1) and in Combination With Selected Direct Oral Anticoagulants (DOACs) in Healthy Older Subjects (Part 2)
- ClinicalTrials.gov ID
- NCT05152420
- Acronym / sponsor ID
- VMX-C001-01
- Conditions
- Coagulation Disorder
- Keywords
- Direct oral anticoagulant (DOAC), Human coagulation factor X
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- VarmX B.V.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single centre, double-blind, randomized, parallel group, placebo-controlled study in healthy subjects conducted in two parts:
Part 1: Single ascending doses in healthy subjects aged 18 to 49 years to assess safety, pharmacokinetics (PK) and pharmacodynamic (PD) effects of VMX-C001.
Part 2: Healthy subjects aged 50 to 79 years to assess safety, PK and PD effects of VMX-C001 in the presence of DOACs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
- Model description
- Placebo controlled, single ascending dose.
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Cohort 1 | Experimental | Drug: VMX-C001, Drug: PlaceboSingle dose cohort |
| Part 1 - Cohort 2 | Experimental | Drug: VMX-C001, Drug: PlaceboSingle dose cohort |
| Part 1 - Cohort 3 | Experimental | Drug: VMX-C001, Drug: PlaceboSingle dose cohort |
| Part 1 - Cohort 4 | Experimental | Drug: VMX-C001, Drug: PlaceboSingle dose cohort |
| Part 1 - Cohort 5 | Experimental | Drug: VMX-C001, Drug: PlaceboSingle dose cohort |
| Part 1 - Cohort 6 | Experimental | Drug: VMX-C001, Drug: PlaceboSingle dose cohort |
| Part 2 - Cohort 1 | Experimental | Drug: VMX-C001, Drug: Placebo, Drug: Apixaban, Drug: Rivaroxaban, Drug: EdoxabanSingle dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 |
| Part 2 - Cohort 2 | Experimental | Drug: VMX-C001, Drug: Placebo, Drug: Apixaban, Drug: Rivaroxaban, Drug: EdoxabanSingle dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 |
| Part 2 - Cohort 3 | Experimental | Drug: VMX-C001, Drug: Placebo, Drug: Apixaban, Drug: Rivaroxaban, Drug: EdoxabanSingle dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 |
| Part 2 - Cohort 4 | Experimental | Drug: VMX-C001, Drug: Placebo, Drug: Apixaban, Drug: Rivaroxaban, Drug: EdoxabanSingle dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 |
| Part 2 - Cohort 5 | Experimental | Drug: VMX-C001, Drug: Placebo, Drug: Apixaban, Drug: Rivaroxaban, Drug: EdoxabanSingle dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 |
| Part 2 - Cohort 6 | Experimental | Drug: VMX-C001, Drug: Placebo, Drug: Apixaban, Drug: Rivaroxaban, Drug: EdoxabanSingle dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 |
| Part 2 - Cohort 7 | Experimental | Drug: VMX-C001, Drug: Placebo, Drug: Apixaban, Drug: Rivaroxaban, Drug: EdoxabanSingle dose cohort of selected FXa DOAC anticoagulant in combination with VMX-C001 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- In Part 1, men and women of any ethnic origin aged between 18 and 49 years of age, inclusive, at the time of Screening.
- In Part 2, men and women of any ethnic origin aged between 50 and 79 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 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 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) ≥30 milli-International units (mIU)/mL).
Key exclusion criteria (35 listed)
- The participant has taken piroxicam in the two weeks prior to the first administration of study drug or DOAC.
- The participant has taken any non-aspirin non-piroxicam NSAID in the week prior to the first administration of study drug or DOAC.
- The participant requires or has taken during the month prior to first administration of study drug or DOAC, vitamin K for therapeutic reasons. Vitamin K not taken for therapeutic purposes is acceptable, e.g. as part of a multivitamin supplement.
- The participant 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 the first administration of study drug or DOAC.
- The participant has received any prescribed oral, systemic or topical medication, including coronavirus disease (COVID)-19 vaccination, within 14 days prior to the first administration of study drug or DOAC (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VMX-C001VMX-C001 is human factor X engineered to be insensitive to factor Xa DOACs | Drug | Part 1 - Cohort 1, Part 1 - Cohort 2, Part 1 - Cohort 3, Part 1 - Cohort 4, Part 1 - Cohort 5, Part 1 - Cohort 6, Part 2 - Cohort 1, Part 2 - Cohort 2, Part 2 - Cohort 3, Part 2 - Cohort 4, Part 2 - Cohort 5, Part 2 - Cohort 6, Part 2 - Cohort 7 |
| PlaceboVMX-C001 matched placebo | Drug | Part 1 - Cohort 1, Part 1 - Cohort 2, Part 1 - Cohort 3, Part 1 - Cohort 4, Part 1 - Cohort 5, Part 1 - Cohort 6, Part 2 - Cohort 1, Part 2 - Cohort 2, Part 2 - Cohort 3, Part 2 - Cohort 4, Part 2 - Cohort 5, Part 2 - Cohort 6, Part 2 - Cohort 7 |
| ApixabanFXa Inhibitor | Drug | Part 2 - Cohort 1, Part 2 - Cohort 2, Part 2 - Cohort 3, Part 2 - Cohort 4, Part 2 - Cohort 5, Part 2 - Cohort 6, Part 2 - Cohort 7 |
| RivaroxabanFXa Inhibitor | Drug | Part 2 - Cohort 1, Part 2 - Cohort 2, Part 2 - Cohort 3, Part 2 - Cohort 4, Part 2 - Cohort 5, Part 2 - Cohort 6, Part 2 - Cohort 7 |
| EdoxabanFXa Inhibitor | Drug | Part 2 - Cohort 1, Part 2 - Cohort 2, Part 2 - Cohort 3, Part 2 - Cohort 4, Part 2 - Cohort 5, Part 2 - Cohort 6, Part 2 - Cohort 7 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1)
Time frame: Up to Day 28
Number of Subjects with One or More Drug Related Adverse Events (AEs) or any Serious AEs
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 2)
Time frame: Up to Day 31
Number of Subjects with One or More Drug Related Adverse Events (AEs) or any Serious AEs
PK of VMX-C001 in plasma after single dose administration - Cmax (Part 1)
Time frame: Up to Day 7
Maximal concentration
PK of VMX-C001 in plasma after single dose administration - tmax (Part 1)
Time frame: Up to Day 7
Time of maximal concentration
PK of VMX-C001 in plasma after single dose administration - t1/2 (Part 1)
Time frame: Up to Day 7
Terminal elimination half-life
PK of VMX-C001 in plasma after single dose administration - AUC0-last (Part 1)
Time frame: Up to Day 7
Area under the concentration-time curve from time of dosing to last measurable concentration
PK of VMX-C001 in plasma after single dose administration - AUC0-inf (Part 1)
Time frame: Up to Day 7
Area under the concentration-time curve from time of dosing extrapolated to infinity
PK of VMX-C001 in plasma after single dose administration - Lambda z (Part 1)
Time frame: Up to Day 7
Terminal elimination rate constant
PK of VMX-C001 in plasma after single dose administration - CL (Part 1)
Time frame: Up to Day 7
Total body clearance
PK of VMX-C001 in plasma after single dose administration - Dose proportionality (Part 1)
Time frame: Up to Day 7
Change in D-dimer, Thrombin-Antithrrombin complexes and prothrombin fragments F1 and F2 following dosing with VMX-C001 (Part 1 and Part 2)
Time frame: Up to Day 28 post dose with VMX-C001
Change from baseline in thrombin generation (ETP) following dosing with VMX-C001 in subjects previously dosed with DOAC anticoagulants (Part 2)
Time frame: Up to 24 hours post dose with VMX-C001
DOAC plasma concentrations (Part 2)
Time frame: Up to Day 5
4 secondary outcomes
Antibodies against VMX-C001 in plasma (Part 1)
Time frame: Up to Day 28
Antibodies against VMX-C001 in plasma (Part 2)
Time frame: Up to Day 31
Antibodies against human coagulation FX in plasma (Part 1)
Time frame: Up to Day 28
Antibodies against human coagulation FX in plasma (Part 2)
Time frame: Up to Day 31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VMX-C001, Apixaban and Rivaroxaban in people with Coagulation Disorder, run by VarmX B.V. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1) (time frame: Up to Day 28). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.