Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05325346 | A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects | PHASE1 | COMPLETED | 12 | — | — | Mar 7, 2022 | Apr 14, 2022 | Jan 11, 2023 | 1 | United States |
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....