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The purpose of this study is to assess the safety, tolerability and effect on Midazolam pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1: BMS-986120 or Placebo | Experimental | BMS-986120 or Placebo multiple dose by mouth as specified |
|
| Panel 2: BMS-986120 or Placebo | Experimental | BMS-986120 or Placebo multiple dose by mouth as specified |
|
| Panel 3: BMS-986120 or Placebo + Midazolam | Experimental | BMS-986120 or Placebo (multiple dose) + Midazolam (single dose) by mouth as specified |
|
| Panel 4: BMS-986120 or Placebo | Experimental | BMS-986120 or Placebo multiple dose by mouth as specified |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986120 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability measured by number of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters | Up to 168 days | |
| Safety and tolerability measured by percent of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters | Up to 168 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) | |
| Time of maximum observed plasma concentration (Tmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Concurrent, or use within 2-weeks of study drug administration, of marketed or investigational, non-steroidal anti-inflammatory compounds (NSAIDS), aspirin or other antiplatelet agents, oral or parenteral anticoagulants
Subjects at screening or prior to first dose with the following abnormal laboratory values upon repeat testing are excluded:
Hemoglobin or hematocrit or platelet count \
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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 |
|---|---|---|---|
| 35758258 | Derived | Merali S, Wang Z, Frost C, Callejo M, Hedrick M, Hui L, Meadows Shropshire S, Xu K, Bouvier M, DeSouza MM, Yang J. New oral protease-activated receptor 4 antagonist BMS-986120: tolerability, pharmacokinetics, pharmacodynamics, and gene variant effects in humans. Platelets. 2022 Oct 3;33(7):969-978. doi: 10.1080/09537104.2022.2088719. Epub 2022 Jun 26. |
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| Placebo | Drug |
|
| Midazolam | Drug |
|
| Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| Area under the concentration-time curve from time zero to 24h [AUC(TAU)] of BMS-986120 and BMT-141464 | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| Concentration at the end of the dosing Interval (Ctau) of BMS-986120 and BMT-141464 | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| Half-life (T-HALF) of BMS-986120 and BMT-141464 | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| Apparent total body clearance (CLT/F) of BMS-986120, Midazolam, and 1'hydroxymidazolam | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| AUC accumulation index (AI_AUC) of BMS-986120 and BMT-141464 | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986120 | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMT-141464 | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMT-141464 | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Midazolam and 1'hydroxymidazolam | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Midazolam and 1'hydroxymidazolam | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight [MR_AUC(INF)] of 1'hydroxymidazolam | Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22) |
| Change from baseline in protease-activated receptor-4 - agonist peptide (PAR4-AP) induced platelet aggregation of BMS-986120 | Part A (Days 1-3) & Part B/C (Days 1-19) |
| ID | Term |
|---|---|
| C000629676 | BMS-986120 |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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