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This study will investigate the safety and interaction of BMS-986177 in healthy volunteers, when administered with Aspirin and/or Clopidogrel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986177 + Aspirin + Clopidogrel (Part 1) | Experimental | BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5) |
|
| BMS-986177 (Part 1) | Experimental | BMS-986177 200 mg capsule twice daily (days 1-5) |
|
| BMS-986177 placebo + Aspirin + Clopidogrel (Part 1) | Placebo Comparator | BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg once daily (day 1) then 75 mg tablet once daily (days 2-5) |
|
| BMS-986177 (Part 2) | Experimental | BMS-986177 200 mg capsule twice daily (days 1-5) |
|
| BMS-986177 placebo + Clopidogrel (Part 2) | Placebo Comparator | BMS-986177 placebo match capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986177 | Drug | BMS-986177 capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to Day 33 | |
| Incidence of Serious Adverse Events (SAEs) | Up to Day 95 | |
| Incidence of Adverse Events (AEs) leading to discontinuation | Up to Day 33 | |
| Number of participants with vital sign abnormalities | Up to Day 33 | |
| Number of participants with 12-lead electrocardiogram (ECG) abnormalities | Up to Day 33 | |
| Number of participants with clinical laboratory abnormalities | Up to Day 33 | |
| Number of participants with physical examination abnormalities | Up to Day 33 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Cmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite | Up to Day 33 |
| Area under the plasma concentration time curve in one dosing interval [AUC(TAU)] |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
For Parts 1 and 2:
• Must be a clopidogrel responder (eg, a decrease in platelet aggregation of at least 30% after a single 600-mg dose of clopidogrel compared with baseline).
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39025971 | Derived | Perera V, Abelian G, Luettgen J, Aronson R, Li D, Wang Z, Zhang L, Lubin S, Merali S, Murthy B. Safety, tolerability, pharmacokinetics and pharmacodynamics of milvexian with aspirin and/or clopidogrel in healthy participants. Sci Rep. 2024 Jul 18;14(1):16591. doi: 10.1038/s41598-024-67182-8. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| C000720754 | milvexian |
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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|
| BMS-986177 + Clopidogrel (Part 2) | Experimental | BMS-986177 200 mg capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5) |
|
| BMS-986177 (Part 3) | Experimental | BMS-986177 200 mg capsule twice daily (days 1-5) |
|
| BMS-986177 placebo + Aspirin (Part 3) | Placebo Comparator | BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) |
|
| BMS-986177 + Aspirin (Part 3) | Experimental | BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) |
|
| Placebo (for BMS-986177) | Other | BMS-986177 placebo match capsule |
|
| Clopidogrel | Drug | Clopidogrel tablet |
|
| Aspirin | Drug | Aspirin tablet |
|
AUC(TAU) of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite
| Up to Day 33 |
| Time of maximum observed concentration (Tmax) | Tmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite | Up to Day 33 |
| Terminal plasma half-life (T-HALF) | T-Half of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite | Up to Day 33 |
| Trough observed plasma concentration (Ctrough) | Ctrough of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite | Up to Day 26 |
| Apparent total body clearance (CLT/F) | CLT/F of BMS-986177, aspirin, clopidogrel | Up to Day 33 |
| Volume of distribution (Vz/F) | Vz/F of BMS-986177, aspirin, clopidogrel | Up to Day 33 |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |