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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01860105 | Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Evaluation | PHASE1 | COMPLETED | 37 | — | — | Sep 1, 2012 | Jan 1, 2013 | Feb 22, 2018 | 1 | France |
To evaluate the dose-response of MDCO-157 (at 3 doses) compared to Plavix (300 mg), using Emax and AUEC with VASP, over 24 hours: * Maximum effect of P2Y12 receptor inhibition (Emax) using VASP (flow cytometry) * Area under the effect of P2Y12 receptor inhibition time curve (AUEC) using VASP (flow cytometry)
| Arm | Type | Description |
|---|---|---|
| 75mg MDCO-157 | ACTIVE_COMPARATOR | iv |
| 150mg MDCO-157 | ACTIVE_COMPARATOR | iv |
| 300mg MDCO-157 | ACTIVE_COMPARATOR | iv |
| 300mg PLAVIX | ACTIVE_COMPARATOR | oral |
| Name | Type | Description |
|---|---|---|
| MDCO-157 | DRUG | intravenous administration |
| PLAVIX | DRUG | oral administration |
Inclusion Criteria * Healthy males or females 18 to 45 years of age, inclusive. * Provide written informed consent for genetic testing and written informed consent for the study before initiation of any study related procedures * Affiliated to the French social security system * Screening and basel...