Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VLX-1005 · 1 trial · 1 indication
Measure the effects of argatroban on the maximum plasma concentration (Cmax) of VLX-1005
Measure the effects of VLX-1005 on the maximum plasma concentration (Cmax) of argatroban
Measure the effects of argatroban on the time to maximum plasma concentration (Tmax) of VLX-1005
Measure the effects of VLX-1005 on the time to maximum plasma concentration (Tmax) of argatroban
Measure the effects of argatroban on the Area Under the Curve \[AUC(inf)\] of VLX-1005
Measure the effects of VLX-1005 on the Area Under the Curve \[AUC(inf)\] of argatroban
The change in impedance from baseline by whole blood aggregometry will be measured to assess the effects of VLX-1005 on platelet aggregation
The change in impedance from baseline by whole blood aggregometry will be measured to assess the effects of argatroban on platelet aggregation
Change in PFA-100 (a platelet pharmacodynamic measure) from baseline, to assess the effects of VLX-1005 on platelet aggregation
Change in PFA-100 (a platelet pharmacodynamic measure) from baseline, to assess the effects of argatroban on platelet aggregation
| Arm | Type | Description |
|---|---|---|
| VLX-1005 | EXPERIMENTAL | Intravenous administration of VLX-1005 with measurements of PK and PD |
| Argatroban | ACTIVE_COMPARATOR | Intravenous administration of argatroban with measurements of PK and PD |
| VLX-1005 and Argatroban | OTHER | Intravenous co-administration of VLX-1005 and argatroban with measurements of PK and PD |
| Name | Type | Description |
|---|---|---|
| VLX-1005 | DRUG | Measurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD |
| Argatroban | DRUG | Measurement and comparison of the effects and potential interactions between VLX-1005 and argatroban on safety, tolerability, PK and PD |
Inclusion Criteria: 1. Healthy, adult, male or female (non-lactating and not of childbearing potential) subjects age 19 to 55 inclusive. 2. Females must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing: 1. hysteroscopic sterilization 2....
VLX-1005 is an investigational small molecule being developed by Cadrenal Therapeutics, Inc. for heparin-induced thrombocytopenia, a hematology condition in which heparin treatment triggers a low platelet count. It has completed a Phase 1 clinical study and has received Orphan Drug and Fast Track designations from the FDA.
VLX-1005 is being developed to treat heparin-induced thrombocytopenia, a serious blood disorder in which the anticoagulant heparin causes an immune reaction that lowers platelets and raises clotting risk. It is investigational and has not been approved for any use. Its only completed trial studied co-administration with argatroban in healthy volunteers.
VLX-1005 targets 12-LOX, also known as 12-lipoxygenase, an enzyme. By acting on this enzyme target, the small molecule is designed to address the platelet and clotting processes involved in heparin-induced thrombocytopenia. The completed Phase 1 study evaluated VLX-1005 given together with argatroban in healthy human subjects.
VLX-1005 is being developed by Cadrenal Therapeutics, Inc., which trades under the ticker CVKD. The company is advancing the small molecule for heparin-induced thrombocytopenia. Development to date includes one completed Phase 1 trial conducted in the United States.
VLX-1005 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The FDA has granted VLX-1005 Orphan Drug and Fast Track designations for its development in heparin-induced thrombocytopenia. It remains investigational and is not approved for commercial use.
VLX-1005 has been studied in one completed Phase 1 trial, NCT05325346, titled a Phase I study of the co-administration of VLX-1005 and argatroban in healthy human subjects. The trial enrolled 12 participants in the United States, was randomized and active controlled, and included healthy volunteers aged 19 years and older.