Heparin-induced ThrombocytopeniaPhase 1NCT05325346
A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects
A Phase 1 study testing VLX-1005 and Argatroban in people with Heparin-induced Thrombocytopenia, run by Veralox Therapeutics at 1 site in United States.
Trial summary
The study is designed to characterize the safety and tolerability of VLX-1005 and argatroban administered intravenously, either alone or in combination; and the pharmacokinetics and pharmacodynamics and potential interaction of both agents in a population of healthy subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Heparin-induced Thrombocytopenia
- What is being tested?
- VLX-1005 and Argatroban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 14 Apr 2022
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female (non-lactating and not of childbearing potential) subjects age 19 to 55 inclusive.
- Females must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
- hysteroscopic sterilization
- bilateral tubal ligation or bilateral salpingectomy
- hysterectomy
- bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
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- Good general health, with no significant medical history. Subjects must have no clinically significant abnormalities at screening, and/or before administration of the initial dose of study drug.
- Body weight ≥ 50 kg at the screening visit.
- Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
- Laboratory values (clinical chemistry and hematology) within the normal reference range. Deviations from this range may be acceptable if they are considered 'not clinically significant' (NCS) by the PI, however, AST and ALT shall be <1.5x ULN. 7. Males who have not been vasectomized prior to participating in the study must agree to use at least 2 approved methods of contraception, or to abstain from sexual intercourse, from randomization until 90 days after their last dose of VLX-1005 and should refrain from donating sperm during that period. 8. Is a non-smoker and must not have used any nicotine products within three months prior to screening.
- 9. Able and willing to attend the necessary visits to the study center.
Who cannot join
- Blood donation or recipient of blood transfusion in previous 12 weeks.
- History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatobiliary, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
- History of neoplastic disease (with the exception of adequately treated nonmelanomatous skin carcinoma).
- Mentally or legally incapacitated (e.g. has significant emotional problems at the time of Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years).
- Fever (body temperature >38 C) or symptomatic viral/bacterial infection or use of antibiotics within 2 weeks prior to Screening.
- Supine resting blood pressure (BP) >140/90 mmHg or heart rate (HR) >100 beats per minute at Screening and at Day -2.
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- Clinically significant abnormality on ECG performed at the Screening Visit or prior to administration of the initial dose of study drug. (Abnormalities include not being in sinus rhythm, IVCD/BBB or QTcF>450 ms for males (470 ms for females)).
- Out of range (on repeat) testing for coagulation tests.
- Clinically significant laboratory abnormalities including: Impaired renal function (estimated creatinine clearance (CrCl) of <80 mL/minute based on CrCl = (140-age [years])(body weight [kg])/(72)(serum creatinine [mg/dL])).
- Positive test for hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus (HIV) antibody at Screening.
- Participants with a positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol, amphetamines, benzodiazepines, opiates, cocaine, cotinine and ethanol).
- Participants with a history of substance abuse or dependency or history of recreational IV drug use (by self-declaration).13. Participant has a suspected history of alcohol abuse in the 6 months prior to screening.
- 14. Use of NSAIDs, aspirin or aspirin-containing medications (and other medications affecting platelet function [for example cilostazol, clopidogrel, ticagrelor, prasugrel, dipyridamole]) in the 14 days prior to dosing with study medication. VerifyNow testing will be performed at check-in to exclude possible use of medications that affect platelet function.
- 15. Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal remedies (such as St. John's Wort [Hypericum perforatum]), beginning 14 days (or 5 half-lives, whichever is longer) before administration of the initial dose of study drug and continuing throughout the study until the final study visit. There may be certain medications that are permitted at the discretion of the PI and Sponsor (including paracetamol/acetaminophen, medications for the treatment of AEs following administration of study drug).
- 16. Subjects who are unlikely to comply with the study protocol or, in the opinion of the PI, would not be a suitable candidate for participation in the study.
- 17. Have participated in any other investigational drug trial within 30 days of dosing in the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Randomized, Three-Period, Three-Sequence Crossover Study of the Effects of Co-administration of Intravenous VLX-1005 With Argatroban on Pharmacokinetics, Pharmacodynamics and Safety in Healthy Adult Subjects
The study is designed to characterize the safety and tolerability of VLX-1005 and argatroban administered intravenously, either alone or in combination; and the pharmacokinetics and pharmacodynamics and potential interaction of both agents in a population of healthy subjects.
Read the detailed description
VLX-1005 is being developed as a treatment for heparin induced thrombocytopenia (HIT), a rare but life threatening illness. Currently, the anticoagulant argatroban remains the standard of care for treating HIT. However, this treatment remains inadequate due to both thrombosis and major bleeding complications that each may exceed 30% of treated HIT patients. These findings are significant to the later stage clinical development of VLX-1005 as a trial of VLX-1005 on top of argatroban therapy would require an understanding of any potential drug-drug interactions- whether direct or via metabolism. Specifically, coadministration of VLX-1005 with argatroban mandates an analysis of the potential effects on PK, pharmacodynamics and bleeding. The current study is designed to address these important questions.
- Conditions
- Heparin-induced Thrombocytopenia
- Being tested
- VLX-1005, Argatroban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLX-1005Drug
Measurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD
ArgatrobanDrug
Measurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD
| Study group | Role | What they receive |
|---|---|---|
| VLX-1005 | Experimental | Intravenous administration of VLX-1005 with measurements of PK and PD Receives: Drug: VLX-1005 |
| Argatroban | Active comparator | Intravenous administration of argatroban with measurements of PK and PD Receives: Drug: Argatroban |
| VLX-1005 and Argatroban | Other | Intravenous co-administration of VLX-1005 and argatroban with measurements of PK and PD Receives: Drug: VLX-1005; Drug: Argatroban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of argatroban on Cmax of VLX-1005
Measure the effects of argatroban on the maximum plasma concentration (Cmax) of VLX-1005
Measured: 0 - 51 hours
Effects of VLX-1005 on Cmax of argatroban
Measure the effects of VLX-1005 on the maximum plasma concentration (Cmax) of argatroban
Measured: 0 - 51 hours
Effects of argatroban on Tmax of VLX-1005
Measure the effects of argatroban on the time to maximum plasma concentration (Tmax) of VLX-1005
Measured: 0 - 51 hours
Effects of VLX-1005 on Tmax of argatroban
Measure the effects of VLX-1005 on the time to maximum plasma concentration (Tmax) of argatroban
Measured: 0 - 51 hours
Effects of argatroban on AUC(inf) of VLX-1005
Measure the effects of argatroban on the Area Under the Curve [AUC(inf)] of VLX-1005
Measured: 0 - 51 hours
Effects of VLX-1005 on AUC(inf) of argatroban
Measure the effects of VLX-1005 on the Area Under the Curve [AUC(inf)] of argatroban
Measured: 0 - 51 hours
Effects of VLX-1005 on whole blood aggregometry
The change in impedance from baseline by whole blood aggregometry will be measured to assess the effects of VLX-1005 on platelet aggregation
Measured: 0 - 9 hours
Effects of argatroban on whole blood aggregometry
The change in impedance from baseline by whole blood aggregometry will be measured to assess the effects of argatroban on platelet aggregation
Measured: 0 - 9 hours
Effects of VLX-1005 on PFA-100
Change in PFA-100 (a platelet pharmacodynamic measure) from baseline, to assess the effects of VLX-1005 on platelet aggregation
Measured: 0 - 9 hours
Effects of argatroban on PFA-100
Change in PFA-100 (a platelet pharmacodynamic measure) from baseline, to assess the effects of argatroban on platelet aggregation
Measured: 0 - 9 hours
Secondary outcomes (3)
Safety as measured by incidence of Treatment Emergent Adverse Events
To assess the effects on subject safety of VLX-1005 and argatroban alone and in combination as measured by incidence of Treatment Emergent Adverse Events as assessed by CTCAE, ver 5.0.
Measured: 0 - 30 days
Effects of VLX-1005 on 12-HETE
12-hydroxyeicosatetraenoic acid (12-HETE), a platelet biomarker, will be measured to assess the effects of VLX-1005 on its production
Measured: 0 - 12 hours
Effects of argatroban on 12-HETE
12-HETE, a platelet biomarker, will be measured to assess the effects of argatroban on its production
Measured: 0 - 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start7 Mar 2022
- Primary completion1 Apr 2022
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heparin-induced ThrombocytopeniaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veralox Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Allen Hunt, MBA, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325346
- Sponsor's protocol ID
- VLX-1005-002
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Randomized, Three-Period, Three-Sequence Crossover Study of the Effects of Co-administration of Intravenous VLX-1005 With Argatroban on Pharmacokinetics, Pharmacodynamics and Safety in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05325346
- Acronym / sponsor ID
- VLX-1005-002
- Conditions
- Heparin-induced Thrombocytopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Veralox TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 13 Apr 2022 (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.
The study is designed to characterize the safety and tolerability of VLX-1005 and argatroban administered intravenously, either alone or in combination; and the pharmacokinetics and pharmacodynamics and potential interaction of both agents in a population of healthy subjects.
Detailed description
VLX-1005 is being developed as a treatment for heparin induced thrombocytopenia (HIT), a rare but life threatening illness. Currently, the anticoagulant argatroban remains the standard of care for treating HIT. However, this treatment remains inadequate due to both thrombosis and major bleeding complications that each may exceed 30% of treated HIT patients. These findings are significant to the later stage clinical development of VLX-1005 as a trial of VLX-1005 on top of argatroban therapy would require an understanding of any potential drug-drug interactions- whether direct or via metabolism. Specifically, coadministration of VLX-1005 with argatroban mandates an analysis of the potential effects on PK, pharmacodynamics and bleeding. The current study is designed to address these important questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VLX-1005 | Experimental | Drug: VLX-1005Intravenous administration of VLX-1005 with measurements of PK and PD |
| Argatroban | Active comparator | Drug: ArgatrobanIntravenous administration of argatroban with measurements of PK and PD |
| VLX-1005 and Argatroban | Other | Drug: VLX-1005, Drug: ArgatrobanIntravenous co-administration of VLX-1005 and argatroban with measurements of PK and PD |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy, adult, male or female (non-lactating and not of childbearing potential) subjects age 19 to 55 inclusive.
- Females must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
- Good general health, with no significant medical history. Subjects must have no clinically significant abnormalities at screening, and/or before administration of the initial dose of study drug.
- Body weight ≥ 50 kg at the screening visit.
- Body Mass Index (BMI) between 18 and 32 kg/m2 inclusive.
Key exclusion criteria (16 listed)
- Blood donation or recipient of blood transfusion in previous 12 weeks.
- History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatobiliary, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
- History of neoplastic disease (with the exception of adequately treated nonmelanomatous skin carcinoma).
- Mentally or legally incapacitated (e.g. has significant emotional problems at the time of Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years).
- Fever (body temperature >38 C) or symptomatic viral/bacterial infection or use of antibiotics within 2 weeks prior to Screening.
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 |
|---|---|---|
| VLX-1005Measurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD | Drug | VLX-1005, VLX-1005 and Argatroban |
| ArgatrobanMeasurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD | Drug | Argatroban, VLX-1005 and Argatroban |
Primary outcome
Effects of argatroban on Cmax of VLX-1005
Time frame: 0 - 51 hours
Measure the effects of argatroban on the maximum plasma concentration (Cmax) of VLX-1005
Effects of VLX-1005 on Cmax of argatroban
Time frame: 0 - 51 hours
Measure the effects of VLX-1005 on the maximum plasma concentration (Cmax) of argatroban
Effects of argatroban on Tmax of VLX-1005
Time frame: 0 - 51 hours
Measure the effects of argatroban on the time to maximum plasma concentration (Tmax) of VLX-1005
Effects of VLX-1005 on Tmax of argatroban
Time frame: 0 - 51 hours
Measure the effects of VLX-1005 on the time to maximum plasma concentration (Tmax) of argatroban
Effects of argatroban on AUC(inf) of VLX-1005
Time frame: 0 - 51 hours
Measure the effects of argatroban on the Area Under the Curve [AUC(inf)] of VLX-1005
Effects of VLX-1005 on AUC(inf) of argatroban
Time frame: 0 - 51 hours
Measure the effects of VLX-1005 on the Area Under the Curve [AUC(inf)] of argatroban
Effects of VLX-1005 on whole blood aggregometry
Time frame: 0 - 9 hours
The change in impedance from baseline by whole blood aggregometry will be measured to assess the effects of VLX-1005 on platelet aggregation
Effects of argatroban on whole blood aggregometry
Time frame: 0 - 9 hours
The change in impedance from baseline by whole blood aggregometry will be measured to assess the effects of argatroban on platelet aggregation
Effects of VLX-1005 on PFA-100
Time frame: 0 - 9 hours
Change in PFA-100 (a platelet pharmacodynamic measure) from baseline, to assess the effects of VLX-1005 on platelet aggregation
Effects of argatroban on PFA-100
Time frame: 0 - 9 hours
Change in PFA-100 (a platelet pharmacodynamic measure) from baseline, to assess the effects of argatroban on platelet aggregation
3 secondary outcomes
Safety as measured by incidence of Treatment Emergent Adverse Events
Time frame: 0 - 30 days
Effects of VLX-1005 on 12-HETE
Time frame: 0 - 12 hours
Effects of argatroban on 12-HETE
Time frame: 0 - 12 hours
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 11 Jan 2023.
- Individual participant dataSharing planned: No
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Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia
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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.
Allen Hunt, MBA principal investigator
Celerion
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 VLX-1005 and Argatroban in people with Heparin-induced Thrombocytopenia, run by Veralox Therapeutics at 1 site in United States.
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 16 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 11 Jan 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 United States. 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?
Effects of argatroban on Cmax of VLX-1005 (time frame: 0 - 51 hours). The study lists 10 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 11 Jan 2023.