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Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs), this study, to be conducted in approximately 36 NHVs, will provide pertinent information in determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12 receptor inhibition effects and in selection of doses that match the antiplatelet effects of 300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK), safety and tolerability of single doses of MDCO-157.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDCO-157 | Drug | intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Response of MDCO-157 (3 doses) compared to Plavix 300 mg | 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:
| 24 hr |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of MDCO-157 and its metabolites | To determine the pharmacokinetic (PK) of MDCO-157, including clopidogrel, clopidogrel carboxylic acid, and clopidogrel H4 thiol active metabolite in plasma | 24 hrs |
| Safety and tolerability |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Pitié-Salpêtrière | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26386578 | Derived | Collet JP, Funck-Brentano C, Prats J, Salem JE, Hulot JS, Guilloux E, Hu MY, He K, Silvain J, Gallois V, Brugier D, Anzaha G, Galier S, Nicolas N, Montalescot G. Intravenous Clopidogrel (MDCO-157) Compared with Oral Clopidogrel: The Randomized Cross-Over AMPHORE Study. Am J Cardiovasc Drugs. 2016 Feb;16(1):43-53. doi: 10.1007/s40256-015-0145-0. |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| PLAVIX | Drug | oral administration |
|
To assess the safety and tolerability of single doses of MDCO 157 (75 mg, 150mg and 300mg) as measured by assessment of AEs and SAEs.
| 48 hrs post each treatment period |
| Dose response of MDCO-157 as assessed by LTA | 24 hours |
| Dose response of MDCO-157 as assess by VerifyNow P2Y12 assay | 24 hours |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |