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A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects

Heparin-induced Thrombocytopenia Clinical Trial

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

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05325346
Study type Interventional
Source Veralox Therapeutics
Contact
Status Completed
Phase Phase 1
Start date March 7, 2022
Completion date April 14, 2022
View Details
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