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The purpose of this study is to investigate the safety and tolerability of BMS-986209 in healthy participants. The first-in-human study is designed in 3 parts that vary based on duration and food effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A:SAD | Experimental | Single Ascending Dose |
|
| Part B: MAD | Experimental | Multiple Ascending Dose |
|
| Part C: DDI | Experimental | Drug-Drug Interaction |
|
| Part A (SAD) Placebo | Experimental |
| |
| Part B (MAD) Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986209 | Drug | Specified Dose on Specified Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) including bleeding | Up to 18 days | |
| Incidence of serious AEs (SAEs) | Up to 44 days | |
| Incidence of AEs leading to discontinuation | Up to 18 days | |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 18 days | |
| Incidence of clinically significant changes in vital signs: Respiratory Rate | Up to 18 days | |
| Incidence of clinically significant changes in vital signs: Seated blood pressure | Up to 18 days | |
| Incidence of clinically significant changes in vital signs: Resting pulse rate | Up to 18 days | |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters | Up to 18 days | |
| Incidence of clinically significant changes in clinical laboratory tests: Hematology tests | Up to 16 days | |
| Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests | Up to 16 days | |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986209 | Up to 18 days | |
| Time of Maximum observed plasma concentration (Tmax) of BMS-986209 | Up to 18 days | |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
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 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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Parts A,B,(Participant, Care Provider, Investigator) Part C is open-labeled and a cross- over design
| BMS-986209 Placebo | Other | Specified Dose on Specified Days |
|
| Itraconazole | Drug | Specified Dose on Specified Days |
|
| Diltiazem | Drug | Specified Dose on Specified Days |
|
| Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests |
| Up to 16 days |
| Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests | Up to 16 days |
| Incidence of clinically significant changes in clinical laboratory tests: Serology tests | Up to 16 days |
| Terminal plasma half-life (T-Half) of BMS-986209 |
| Up to 18 days |
| Incidence of Adverse Events (AEs) including bleeding | Up to 18 days |
| Incidence of serious AEs (SAEs) | Up to 44 days |
| Incidence of AEs leading to discontinuation | Up to 18 days |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 18 days |
| Incidence of clinically significant changes in vital signs: Respiratory Rate | Up to 18 days |
| Incidence of clinically significant changes in vital signs: Seated blood pressure | Up to 18 days |
| Incidence of clinically significant changes in vital signs: Resting pulse rate | Up to 18 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters | Up to 18 days |
| Incidence of clinically significant changes in clinical laboratory tests: Hematology tests | Up to 16 days |
| Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests | Up to 16 days |
| Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests | Up to 16 days |
| Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests | Up to 16 days |
| Incidence of clinically significant changes in clinical laboratory tests: Serology tests | Up to 16 days |
| Percent change from baseline in plasma activated partial thromboplastin time (aPTT) levels | Up to 16 days |
| Percent change from baseline in factor XI (FXI) clotting activity | Up to 16 days |
| FDA Safety Alerts and Recalls | View source |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D004110 | Diltiazem |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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