Trial Outcomes & Findings for A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy Participants (NCT NCT05093790)
NCT ID: NCT05093790
Last Updated: 2023-12-05
Results Overview
The change from baseline in thrombus area post-treatment with BMS-986141 versus pretreatment. Baseline is defined as the last non-missing result (including repeated and unscheduled assessments) with a collection date-time less than the datetime of study medication.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Baseline, Day 1 hour 2, Day 2 hour 24
Results posted on
2023-12-05
Participant Flow
58 participants received study treatment
Participant milestones
| Measure |
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141
Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2.
|
Arm 2: 75 mg Aspirin + 4 mg BMS-986141
Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2.
|
Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141
Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2.
|
Arm 4: Heathy Participants
Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
16
|
11
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141
Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2.
|
Arm 2: 75 mg Aspirin + 4 mg BMS-986141
Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2.
|
Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141
Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2.
|
Arm 4: Heathy Participants
Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Failure to meet continuation criteria
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy Participants
Baseline characteristics by cohort
| Measure |
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141
n=16 Participants
Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2.
|
Arm 2: 75 mg Aspirin + 4 mg BMS-986141
n=15 Participants
Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2.
|
Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141
n=16 Participants
Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2.
|
Arm 4: Heathy Participants
n=11 Participants
Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.6 Years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
66.3 Years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
62.3 Years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
31.0 Years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
58.3 Years
STANDARD_DEVIATION 15.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 1 hour 2, Day 2 hour 24Population: Biomarker population-all treated participants who had any available biomarker data
The change from baseline in thrombus area post-treatment with BMS-986141 versus pretreatment. Baseline is defined as the last non-missing result (including repeated and unscheduled assessments) with a collection date-time less than the datetime of study medication.
Outcome measures
| Measure |
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141
n=15 Participants
Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2.
|
Arm 2: 75 mg Aspirin + 4 mg BMS-986141
n=15 Participants
Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2.
|
Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141
n=15 Participants
Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2.
|
Arm 4: Heathy Participants
n=11 Participants
Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Thrombus Area
Post-treatment Day 2, Hour 24, Low Shear
|
20.7 Percent Change
Standard Deviation 134.6
|
579.6 Percent Change
Standard Deviation 2125.4
|
31.0 Percent Change
Standard Deviation 130.0
|
-2.5 Percent Change
Standard Deviation 41.6
|
|
Percent Change From Baseline in Thrombus Area
On-treatment Day 1, Hour 2, Low Shear
|
10.0 Percent Change
Standard Deviation 260.3
|
538.6 Percent Change
Standard Deviation 1803.3
|
104.2 Percent Change
Standard Deviation 383.5
|
-14.9 Percent Change
Standard Deviation 50.2
|
|
Percent Change From Baseline in Thrombus Area
On-treatment Day 1, Hour 2, High Shear
|
-23.0 Percent Change
Standard Deviation 24.1
|
-18.4 Percent Change
Standard Deviation 27.5
|
-24.2 Percent Change
Standard Deviation 17.2
|
-27.7 Percent Change
Standard Deviation 24.4
|
|
Percent Change From Baseline in Thrombus Area
Post-treatment Day 2, Hour 24, High Shear
|
-4.8 Percent Change
Standard Deviation 30.0
|
-3.5 Percent Change
Standard Deviation 67.1
|
-10.6 Percent Change
Standard Deviation 24.0
|
-23.0 Percent Change
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2Population: All treated participants
The number of participants with abnormal vital sign values. The criteria used for classifying vital sign results as markedly abnormal is listed below. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication. For Treatment Arms 1, 2, and 3, a baseline chamber run was performed approximately 2 hours after background therapy (ticagrelor, aspirin, or ticagrelor + aspirin) and prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. For Treatment Arm 4, a baseline chamber run was performed prior to BMS-986141 administration. A second chamber run was performed 2 hours following oral administration of BMS-986141. Participants received background therapy before the final chamber run, and the final chamber run was performed on Day 2, approximately 24 hours after BMS-986141 dosing.
Outcome measures
| Measure |
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141
n=16 Participants
Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2.
|
Arm 2: 75 mg Aspirin + 4 mg BMS-986141
n=15 Participants
Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2.
|
Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141
n=16 Participants
Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2.
|
Arm 4: Heathy Participants
n=11 Participants
Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Abnormal Vital Signs
DIASTOLIC BLOOD PRESSURE (MMHG) Day 1 > 90 AND CHANGE FROM BASELINE > 10
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
DIASTOLIC BLOOD PRESSURE (MMHG) Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run < 55 AND CHANGE FROM BASELINE < -10
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
DIASTOLIC BLOOD PRESSURE (MMHG) Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
DIASTOLIC BLOOD PRESSURE (MMHG) 2 hours Post-Chamber Run > 90 AND CHANGE FROM BASELINE > 10
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run > 90 AND CHANGE FROM BASELINE > 10
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
DIASTOLIC BLOOD PRESSURE (MMHG) 24 hours Pre-Chamber Run < 55 AND CHANGE FROM BASELINE < -10
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
HEART RATE (BEATS/MIN) Day 1 HR < 55 AND CHANGE FROM BASELINE < -15
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
HEART RATE (BEATS/MIN) Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
HEART RATE (BEATS/MIN) Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
HEART RATE (BEATS/MIN) 2 Hour Pre-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
HEART RATE (BEATS/MIN) 2 Hour Post-Chamber Run HR < 55 AND CHANGE FROM BASELINE < -15
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Day 1
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Pre-Chamber Run
|
4 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 Post-Chamber Run
|
5 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Pre-Chamber Run
|
2 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 2 Hour Post-Chamber Run
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Pre-Chamber Run
|
1 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
RESPIRATORY RATE (BREATHS/MIN) > 16 OR CHANGE FROM BASELINE > 10 24 Hour Post-Chamber Run
|
0 Participants
|
2 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 Day 1 Pre-Chamber Run
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Pre-Chamber Run
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 2 Hour Post-Chamber Run
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Pre-Chamber Run
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
SYSTOLIC BLOOD PRESSURE (MMHG) > 140 AND CHANGE FROM BASELINE > 20 24 Hour Post-Chamber Run
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Day 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Vital Signs
TEMPERATURE (C) > 38.3 OR CHANGE FROM BASELINE > 1.6 Pre-Chamber Run
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Electrocardiograms were collected at check-in, and 2 and 24 hours after dosingPopulation: All treated participants
The number of participants with abnormal electrocardiogram values. The criteria used for classifying electrocardiogram results as markedly abnormal is listed below. The 2-hour and 24-hour ECGs should are performed prior to the Badimon Chamber run. Baseline is defined as the last non-missing result with a collection date-time less than the date-time of the first dose of study medication.
Outcome measures
| Measure |
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141
n=16 Participants
Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2.
|
Arm 2: 75 mg Aspirin + 4 mg BMS-986141
n=15 Participants
Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2.
|
Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141
n=16 Participants
Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2.
|
Arm 4: Heathy Participants
n=11 Participants
Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
PR INTERVAL, AGGREGATE (MSEC) Baseline <210
|
5 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
PR INTERVAL, AGGREGATE (MSEC) Baseline >=210
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <210
|
4 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
PR INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=210
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QRS DURATION, AGGREGATE (MSEC) Baseline <120
|
5 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QRS DURATION, AGGREGATE (MSEC) Baseline >=120
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 <120
|
5 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QRS DURATION, AGGREGATE (MSEC) Day 2, Hour 24 >=120
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QT INTERVAL, AGGREGATE (MSEC) Baseline <500
|
5 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QT INTERVAL, AGGREGATE (MSEC) Baseline >=500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <500
|
5 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QT INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QTCF INTERVAL, AGGREGATE (MSEC) Baseline <450
|
5 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QTCF INTERVAL, AGGREGATE (MSEC) Baseline >=450
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 <450
|
5 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
QTCF INTERVAL, AGGREGATE (MSEC) Day 2, Hour 24 >=450
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 24 hours post dosePopulation: All treated participants
The number of participants with abnormal clinical laboratory results. The criteria used for classifying laboratory test results as markedly abnormal is listed below.
Outcome measures
| Measure |
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141
n=16 Participants
Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2.
|
Arm 2: 75 mg Aspirin + 4 mg BMS-986141
n=15 Participants
Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2.
|
Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141
n=16 Participants
Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2.
|
Arm 4: Heathy Participants
n=11 Participants
Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Clinical Lab Abnormalities
BLOOD, URINE (N/A)-Abnormal High
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
HEMOGLOBIN (G/DL)-Abnormal Low
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
HEMATOCRIT (%)-Abnormal Low
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
ERYTHROCYTES (X10*6 C/UL)-Abnormal Low
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
LEUKOCYTES (X10*3 C/UL)-Abnormal Low
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
LEUKOCYTES (X10*3 C/UL)-Abnormal High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
NEUTROPHILS (ABSOLUTE) (X10*3 C/UL)-Abnormal Low
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
BLOOD UREA NITROGEN (MG/DL)-Abnormal High
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
POTASSIUM, SERUM (MEQ/L)-Abnormal Low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
CHLORIDE, SERUM (MEQ/L)-Abnormal High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
CALCIUM, TOTAL (MG/DL)-Abnormal Low
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
PHOSPHORUS, INORGANIC (MG/DL)-Abnormal Low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
MAGNESIUM, SERUM (MEQ/L)-Abnormal Low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
GLUCOSE, FASTING SERUM (MG/DL)-Abnormal Low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
GLUCOSE, FASTING SERUM (MG/DL)-Abnormal High
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
PROTEIN, TOTAL (G/DL) -Abnormal Low
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
ALBUMIN (G/DL)-Abnormal Low
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
CREATINE KINASE (U/L)-Abnormal High
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
PROTEIN, URINE (N/A)-Abnormal High
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
GLUCOSE, URINE (N/A)-Abnormal High
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
RBC, URINE (HPF)-Abnormal High
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Experiencing Clinical Lab Abnormalities
WBC, URINE (HPF)-Abnormal High
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose up to 8 days post last dosePopulation: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Outcome measures
| Measure |
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141
n=16 Participants
Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2.
|
Arm 2: 75 mg Aspirin + 4 mg BMS-986141
n=15 Participants
Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2.
|
Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141
n=16 Participants
Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2.
|
Arm 4: Heathy Participants
n=11 Participants
Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
|
6 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
Adverse Events
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 2: 75 mg Aspirin + 4 mg BMS-986141
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 4: Heathy Participants
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: 90 mg Ticagrelor + 4 mg BMS-986141
n=16 participants at risk
Single oral dose of 90 mg ticagrelor alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Twice daily dosing of ticagrelor will be continued on Day 2.
|
Arm 2: 75 mg Aspirin + 4 mg BMS-986141
n=15 participants at risk
Single oral dose of 75 mg aspirin alone, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). Daily dosing of aspirin will continue on Day 2.
|
Arm 3: 90 mg Ticagrelor + 75 mg Aspirin + 4 mg BMS-986141
n=16 participants at risk
Single oral dose of 90 mg ticagrelor + 75 mg aspirin, followed by a single oral dose of 4 mg BMS-986141 approximately 2 hours later (Day 1). A second dose of ticagrelor will be taken approximately 12 hours after the first dose. Ticagrelor + aspirin dosing will continue on Day 2.
|
Arm 4: Heathy Participants
n=11 participants at risk
Heathy Participants received a single dose of 4 mg BMS-986141 on Day 1.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
6.2%
1/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/15 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
6.2%
1/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/11 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/15 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
6.2%
1/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/11 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
|
Infections and infestations
COVID-19
|
12.5%
2/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/15 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
9.1%
1/11 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.2%
1/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/15 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/11 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/15 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
12.5%
2/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/11 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/15 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/11 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/15 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
6.2%
1/16 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
0.00%
0/11 • Adverse events were assessed from first dose to 30 days following last dose, up to approximately 32 days.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER