Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986141 · 3 trials · 2 indications
The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated participants.
The percentage of participants with composite of major bleeding and CRNM bleeding was to be reported. Point estimates and 95% CIs for event rates were to be presented by treatment, together with point estimates and 95% CIs for the difference of event rates between each BMS-986141 arm and placebo.
Serious adverse event (SAE) Adverse event (AE) Electrocardiogram (ECG)
| Arm | Type | Description |
|---|---|---|
| BMS-986141 0.8mg | EXPERIMENTAL | BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets) |
| BMS-986141 4.8mg | EXPERIMENTAL | BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets) |
| Placebo | PLACEBO_COMPARATOR | Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets) |
| BMS-986141 and Dilitazem | EXPERIMENTAL | - |
| 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 | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| BMS-986141 | DRUG | - |
| Aspirin | DRUG | - |
| Placebo | OTHER | - |
| Dilitazem | DRUG | Single dose BMS-986141 and Multiple doses of Dilitazem |
| Itraconazole | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Male or female, age 18 or older * Must have had a very recent stroke or transient ischemic attack ("mini stroke") that can be confirmed by the study doctor * Able to be assig...
BMS 986141 is an investigational small molecule being developed for cardiovascular conditions including atherothrombotic diseases, ischemic stroke, and thrombosis. It is currently in clinical development and has not been approved by the FDA. The drug is being studied to potentially reduce the chances of additional strokes or mini strokes.
BMS 986141 is a protease activated receptor-4 (PAR-4) antagonist, as indicated by the clinical trial title. It works by targeting this receptor, which is involved in platelet activation and thrombosis. By blocking PAR-4, the drug aims to reduce thrombotic events in conditions like ischemic stroke and atherothrombotic diseases.
BMS 986141 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY on the stock exchange. The company is conducting clinical trials to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of this investigational drug in various patient populations.
BMS 986141 is in Phase 1 of clinical development, according to the overall phase designation. However, one completed trial (NCT02671461) was a Phase 2 study. The drug is investigational and not yet approved by regulatory authorities. All listed trials for BMS 986141 have been completed.
BMS 986141 has been studied in four completed clinical trials. NCT02341638 was a Phase 1 single and multiple ascending dose study in healthy subjects. NCT02671461 was a Phase 2 safety and efficacy study in patients with thrombosis. NCT02922452 and NCT02957448 were Phase 1 drug interaction studies with diltiazem and rifampin, respectively.
Yes, BMS 986141 and BMS-986141 refer to the same drug. The hyphenated version is used in clinical trial titles, while the non-hyphenated form appears in other contexts. Both names identify the same investigational protease activated receptor-4 antagonist being developed by Bristol-Myers Squibb.