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The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.
Maximum Age:
Part A SAD 65 years
Part B MAD 75 years
Part C MAD Japanese 75 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Panel 1: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo single dose by mouth as specified |
|
| Part A Panel 2: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo single dose by mouth as specified |
|
| Part A Panel 3: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo single dose by mouth as specified |
|
| Part A Panel 4: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo single dose by mouth as specified |
|
| Part A Panel 5: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo single dose by mouth as specified |
|
| Part A Panel 6: BMS-986141 or Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986141 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations | Serious adverse event (SAE) Adverse event (AE) Electrocardiogram (ECG) | Up to 30 days post discontinuation of dosing or last participation in the study |
| Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations | Up to 30 days post discontinuation of dosing or last participation in the study | |
| Safety measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations | Up to 30 days post discontinuation of dosing or last participation in the study | |
| Tolerability measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations | Up to 30 days post discontinuation of dosing or last participation in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 | |
| Time of maximum observed plasma concentration (Tmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials, Llc | Cypress | California | 90630 | United States | ||
| Ppd Development, Lp |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37394920 | Derived | Merali S, Wang Z, Frost C, Meadows-Shropshire S, Hawthorne D, Yang J, Seiffert D. First-in-human study to assess the safety, pharmacokinetics, and pharmacodynamics of BMS-986141, a novel, reversible, small-molecule, PAR4 agonist in non-Japanese and Japanese healthy participants. Platelets. 2023 Dec;34(1):2222846. doi: 10.1080/09537104.2023.2222846. |
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BMS-986141 or Placebo single dose by mouth as specified |
|
| Part A Panel 7: BMS-986141 | Experimental | Single dose by mouth as specified |
|
| Part A Panel 8: BMS-986141 | Experimental | Single dose by mouth as specified |
|
| Part B Panel 1: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified |
|
| Part B Panel 2: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified |
|
| Part B Panel 3: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified |
|
| Part C Panel 1: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified |
|
| Part C Panel 2: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified |
|
| Part C Panel 3: BMS-986141 or Placebo | Experimental | BMS-986141 or Placebo by mouth as specified |
|
| Part D Panel 1: BMS-986141 and Aspirin | Experimental | BMS-986141 and Aspirin by mouth as specified |
|
| Part D Panel 1: Placebo matching BMS-986141 and Aspirin | Placebo Comparator | BMS-986141 placebo and Aspirin by mouth as specified |
|
| Part E Panel 1: BMS-986141 and Itraconazole | Experimental | BMS-986141 and Itraconazole by mouth as specified |
|
| Placebo | Drug |
|
| Aspirin | Drug |
|
| Itraconazole | Drug |
|
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 |
| Concentration at 24 hours (C24) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 |
| Half-life (T-HALF) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 |
| Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 |
| AUC accumulation index (AI_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose | Up to Day 14 |
| Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551 | Up to Day 14 |
| MR_Cmax of BMT-162853, BMT-162856, and BMT-181551 | Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) | Up to Day 14 |
| MR_AUC(INF) of BMT-162853, BMT-162856, and BMT-181551 | Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)] | Up to Day 14 |
| MR_AUC(0-T) of BMT-162853, BMT-162856, and BMT-181551 | Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight [MR_AUC(0-T)] | Up to Day 14 |
| MR_AUC(TAU) of BMT-162853, BMT-162856, and BMT-181551 | Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] | Up to Day 14 |
| Safety of multiple doses of BMS-986141 and aspirin in healthy subjects | Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations. | Up to 30 days post discontinuation of dosing or last participation in the study |
| Tolerability of multiple doses of BMS-986141 and aspirin in healthy subjects | Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations | Up to 30 days post discontinuation of dosing or last participation in the study |
| Safety of BMS-986141 and itraconazole in healthy subjects | Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations | Up to 30 days post discontinuation of dosing or last participation in the study |
| Tolerability of BMS-986141 and itraconazole in healthy subjects | Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations | Up to 30 days post discontinuation of dosing or last participation in the study |
| Austin |
| Texas |
| 78744 |
| United States |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000729678 | BMS-986141 |
| D001241 | Aspirin |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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