Heart Failure
Conditions
Brief summary
A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function
Interventions
DRUGHNO Donor
Infusion
DRUGPlacebo
Infusion
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Actively being hospitalized for acute decompensated heart failure * At least 1 administration of IV diuretic for the current episode * Be randomized within 18 hours of first dose of IV diuretic for current episode for Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II * Have shortness of breath at rest or with minimal exertion after administration of 1 dose of IV diuretic * Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40%
Exclusion criteria
* Systolic blood pressure \<105mm Hg or \>160mm Hg or heart rate \<50 or \>130 bpm * Have an active infection requiring IV anti-microbial treatment * Be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening * Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening * Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis) Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | From start of infusion up to 6 hours post end of infusion | Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) \< 90 mm Hg (confirmed by a repeated value \< 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Troponin T From Baseline to Hour 24, 48, and 72 | from baseline to Hour 24, 48, and 72 | Baseline = Last non-missing result with a collection date-time less than or on the date-time of the start of infusion of study drug |
| Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 0, 24, 48, 72, 120 hour or discharge; Day 32 | Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide) |
| Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | Hours 6, 12, 24, 48, and 72 | Endpoint was measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24, 48, and 72. Participants were asked to report their absolute current severity of dyspnea on an 11-point numerical rating scale (NRS; range 0 to 10). The numerical rating scale (NRS) was used to assess the degree of dyspnea (breathlessness), measured using an 11-point scale provided by the Sponsor. A score of 0 represents I am not breathless at all and 10 represents I am the most breathless I can possibly imagine. |
| Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion | From start of infusion up to 6 hours post end of infusion | The percentage of participants experiencing symptoms of hypotension up to 6 hours post-treatment was reported for each arm. |
| Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value) | From start of infusion up to 6 hours post end of infusion | The percentage of participants experiencing SBP \< 90 mm Hg (confirmed by a repeated value) up to 6 hours post-treatment was reported for each arm. |
| Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32 | 32 days | Number of participants who experienced an in-study SAE. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. |
| Number of Participants Who Discontinued Due to Hypotension | up to 120 hours (for AEs); up to 32 days (for SAEs) | Number of participants who discontinued study treatment due to hypotension. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Hypotension defined as systolic blood pressure (SBP) \< 90 mmHg. |
| Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | up to 120 hours (for AEs); up to 32 days (for SAEs) | Number of participants who discontinued study treatment, experienced a down-titration (dose reduction) or dose interruption due to decreased blood pressure/hypotension are reported below. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. If the participant experienced systolic blood pressure (SBP) \< 95 mm Hg, without symptoms related to hypotension, the measurement was repeated within 15 minutes. If the SBP remained \< 95 mm Hg, the dose reduction occurred. |
| Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours | up to 120 hours | Number of participants who experienced an in-study AE. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment. |
| Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | to 120 hours | Number of participants who experienced an in-study Hematology marked laboratory abnormality (reported in \> 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 |
| Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | to 120 hours | Number of participants who experienced an in-study Chemistry marked laboratory abnormality (reported in \> 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 |
| Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | to 120 hours | Number of participants who experienced an in-study Urinalysis marked laboratory abnormality (reported in \> 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 |
| Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | to 120 hours | The change in baseline for vital signs was reported for each arm. |
| Change in Vital Signs From Baseline to 120 Hours - Heart Rate | to 120 hours | The change in baseline for vital signs was reported for each arm. |
| Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate | to 120 hours | The change in baseline for vital signs was reported for each arm. |
| Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | through 182 days | Number of participants who died (all- cause and CV related) through Day 182. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 CV=Cardiovascular |
| Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate | to 120 hours | The change in baseline for ECGs was reported for each arm. |
| Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | to 120 hours | The change in baseline for ECGs was reported for each arm. |
| Change in Physical Measurements From Baseline to 120 Hours | to 120 hours | The change in baseline for physical measurements was reported for each arm. |
| Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L | to 120 hours | The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only. |
| Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L | to 120 hours | The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only. |
| Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | to 120 hours | The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only. |
| Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | to 120 hours | The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only. |
| Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL | to 120 hours | The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only. |
| Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L | to 120 hours | The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only. |
| Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L) | to 120 hours | The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only. |
| Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L) | to 120 hours | The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only. |
| Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L) | to 120 hours | The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only. |
| Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion | to 120 hours | The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only. |
| Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion | to 120 hours | The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only. |
| Change in Vital Signs From Baseline to 120 Hours - Temperature | to 120 hours | The change in baseline for vital signs was reported for each arm. |
Countries
Argentina, Canada, Czechia, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
Main study cohorts: 100 participants in Part I and 222 in Part II were assigned to treatment (322 randomized in total), of which 97 and 214, respectively, were treated (311 total treated). Reasons not treated (Part I): 3 other reasons. Reasons not treated (Part II): 2 no longer met study criteria; 1 adverse event (AE); 5 other reasons. Japanese-specific cohort: 18 participants were randomized and treated in Part II (Japan cohort)
Participants by arm
| Arm | Count |
|---|---|
| Placebo - Part I Escalating dose of placebo (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours) | 48 |
| BMS-986231 - Part I Escalating dose of BMS-986231 (3 µg/kg/min for 4 hours, then 6 µg/kg/min for another 4 hours, then 12 µg/kg/min for the remaining 40 hours) | 49 |
| Placebo - Part II Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours | 71 |
| BMS-986231 6 µg/kg/Min - Part II BMS-986231 dose of 6 µg/kg/min for 48 hours | 71 |
| BMS-986231 12 µg/kg/Min - Part II BMS-986231 dose of 12 µg/kg/min for 48 hours | 72 |
| Placebo - Part II (Japan Cohort) Matching placebo dose of 6 µg/kg/min or 12 µg/kg/min for 48 hours for Japanese participants | 6 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 6 µg/kg/min for 48 hours for Japanese participants | 6 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) BMS-986231 dose of 12 µg/kg/min for 48 hours for Japanese participants | 6 |
| Total | 329 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| 182-Day Follow-Up Period | Alive, per civil unit | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| 182-Day Follow-Up Period | Alive, per Family doctor | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| 182-Day Follow-Up Period | Alive, per national insurance system | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 182-Day Follow-Up Period | Death | 3 | 3 | 11 | 12 | 9 | 0 | 0 | 1 |
| 182-Day Follow-Up Period | No cont D182 FU, Sponsor admin reason | 0 | 0 | 0 | 0 | 0 | 5 | 3 | 4 |
| 182-Day Follow-Up Period | Participant withdrew consent | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| 182-Day Follow-Up Period | Vital status collected via EMR | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| 182-Day Follow-Up Period | withdrew from D5, D32/182 forms not done | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| 32-Day Follow-Up Period | Death | 2 | 0 | 5 | 6 | 3 | 0 | 0 | 0 |
| 32-Day Follow-Up Period | Family doctor OK'd participant, per call | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| 32-Day Follow-Up Period | Lost to Follow-up | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| 32-Day Follow-Up Period | Participant refused to visit | 0 | 1 | 2 | 0 | 2 | 0 | 0 | 0 |
| 32-Day Follow-Up Period | Participant withdrew consent | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 |
| 32-Day Follow-Up Period | Poor/non-compliance | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| 32-Day Follow-Up Period | withdrew from Day 5, D32 form not done | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period | Death | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Treatment Period | Participant refuses assessments | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period | Participant withdrew consent | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | BMS-986231 - Part I | Placebo - Part II | BMS-986231 6 µg/kg/Min - Part II | BMS-986231 12 µg/kg/Min - Part II | Placebo - Part II (Japan Cohort) | BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Placebo - Part I | BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 64.6 Years STANDARD_DEVIATION 12.23 | 67.3 Years STANDARD_DEVIATION 11.52 | 69.2 Years STANDARD_DEVIATION 11.41 | 70.0 Years STANDARD_DEVIATION 11.52 | 65.3 Years STANDARD_DEVIATION 17.88 | 69.5 Years STANDARD_DEVIATION 13.31 | 66.0 Years STANDARD_DEVIATION 12.23 | 76.7 Years STANDARD_DEVIATION 10.48 | 67.9 Years STANDARD_DEVIATION 11.94 |
| Age, Customized 65 -to <=75 years | 15 Participants | 36 Participants | 26 Participants | 30 Participants | 0 Participants | 1 Participants | 22 Participants | 2 Participants | 132 Participants |
| Age, Customized < 65 years | 24 Participants | 21 Participants | 23 Participants | 19 Participants | 3 Participants | 3 Participants | 17 Participants | 1 Participants | 111 Participants |
| Age, Customized >75 years | 10 Participants | 14 Participants | 22 Participants | 23 Participants | 3 Participants | 2 Participants | 9 Participants | 3 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 9 Participants | 11 Participants | 11 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 18 Participants | 23 Participants | 20 Participants | 0 Participants | 0 Participants | 44 Participants | 0 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 44 Participants | 37 Participants | 41 Participants | 6 Participants | 6 Participants | 4 Participants | 6 Participants | 147 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 6 Participants | 6 Participants | 0 Participants | 6 Participants | 24 Participants |
| Race/Ethnicity, Customized Black or African American | 11 Participants | 4 Participants | 7 Participants | 4 Participants | 0 Participants | 0 Participants | 11 Participants | 0 Participants | 37 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 37 Participants | 63 Participants | 62 Participants | 66 Participants | 0 Participants | 0 Participants | 35 Participants | 0 Participants | 263 Participants |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 20 Participants | 15 Participants | 0 Participants | 1 Participants | 8 Participants | 2 Participants | 74 Participants |
| Sex: Female, Male Male | 39 Participants | 53 Participants | 51 Participants | 57 Participants | 6 Participants | 5 Participants | 40 Participants | 4 Participants | 255 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 48 | 3 / 49 | 11 / 71 | 12 / 71 | 9 / 72 | 0 / 6 | 0 / 6 | 1 / 6 |
| other Total, other adverse events | 18 / 48 | 40 / 49 | 47 / 71 | 43 / 71 | 54 / 72 | 2 / 6 | 6 / 6 | 6 / 6 |
| serious Total, serious adverse events | 11 / 48 | 14 / 49 | 23 / 71 | 15 / 71 | 15 / 72 | 1 / 6 | 0 / 6 | 1 / 6 |
Outcome results
Primary
Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion
Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) \< 90 mm Hg (confirmed by a repeated value \< 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion
Time frame: From start of infusion up to 6 hours post end of infusion
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Part I | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | clinically relevant hypotension | 8.3 Percentage of participants |
| Placebo - Part I | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | confirmed SBP < 90 mmHg | 6.3 Percentage of participants |
| Placebo - Part I | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | symptoms of hypotension | 2.1 Percentage of participants |
| BMS-986231 - Part I | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | confirmed SBP < 90 mmHg | 20.4 Percentage of participants |
| BMS-986231 - Part I | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | symptoms of hypotension | 6.1 Percentage of participants |
| BMS-986231 - Part I | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | clinically relevant hypotension | 20.4 Percentage of participants |
| Placebo - Part II | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | confirmed SBP < 90 mmHg | 18.3 Percentage of participants |
| Placebo - Part II | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | clinically relevant hypotension | 18.3 Percentage of participants |
| Placebo - Part II | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | symptoms of hypotension | 1.4 Percentage of participants |
| BMS-986231 6 µg/kg/Min - Part II | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | clinically relevant hypotension | 21.1 Percentage of participants |
| BMS-986231 6 µg/kg/Min - Part II | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | symptoms of hypotension | 2.8 Percentage of participants |
| BMS-986231 6 µg/kg/Min - Part II | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | confirmed SBP < 90 mmHg | 21.1 Percentage of participants |
| BMS-986231 12 µg/kg/Min - Part II | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | symptoms of hypotension | 8.3 Percentage of participants |
| BMS-986231 12 µg/kg/Min - Part II | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | clinically relevant hypotension | 34.7 Percentage of participants |
| BMS-986231 12 µg/kg/Min - Part II | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | confirmed SBP < 90 mmHg | 29.2 Percentage of participants |
| Placebo - Part II (Japan Cohort) | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | symptoms of hypotension | 0 Percentage of participants |
| Placebo - Part II (Japan Cohort) | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | clinically relevant hypotension | 0 Percentage of participants |
| Placebo - Part II (Japan Cohort) | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | confirmed SBP < 90 mmHg | 0 Percentage of participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | symptoms of hypotension | 0 Percentage of participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | clinically relevant hypotension | 33.3 Percentage of participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | confirmed SBP < 90 mmHg | 33.3 Percentage of participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | clinically relevant hypotension | 50.0 Percentage of participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | symptoms of hypotension | 0 Percentage of participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion | confirmed SBP < 90 mmHg | 50.0 Percentage of participants |
95% CI: [0.83, 14.53]
95% CI: [-0.02, 0.28]
95% CI: [0.31, 75.47]
95% CI: [-0.06, 0.15]
95% CI: [1.01, 14.66]
95% CI: [0, 0.29]
95% CI: [0.58, 2.43]
95% CI: [-0.11, 0.16]
95% CI: [1.04, 3.59]
95% CI: [0.18, 54.35]
95% CI: [-0.05, 0.09]
95% CI: [0.58, 2.43]
95% CI: [-0.11, 0.16]
95% CI: [0.01, 0.31]
95% CI: [0.91, 149.72]
95% CI: [-0.01, 0.16]
95% CI: [0.87, 3.21]
95% CI: [-0.04, 0.25]
95% CI: [-0.17, 0.78]
95% CI: [-0.17, 0.78]
95% CI: [-0.04, 0.88]
95% CI: [-0.04, 0.88]
Secondary
Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate
The change in baseline for ECGs was reported for each arm.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part I | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate | -5.3 beats/min | Standard Deviation 9.36 |
| BMS-986231 - Part I | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate | -6.8 beats/min | Standard Deviation 21.31 |
| Placebo - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate | -7.1 beats/min | Standard Deviation 17.46 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate | -5.1 beats/min | Standard Deviation 18.64 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate | -6.1 beats/min | Standard Deviation 17.33 |
| Placebo - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate | 2.0 beats/min | Standard Deviation 10.72 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate | -13.0 beats/min | Standard Deviation 12.62 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate | -5.2 beats/min | Standard Deviation 14.85 |
Secondary
Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration
The change in baseline for ECGs was reported for each arm.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Part I | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | PR Interval, Aggregate, msec | -17.4 msec | Standard Deviation 66.31 |
| Placebo - Part I | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QRS Duration, Aggregate, msec | 5.1 msec | Standard Deviation 22.19 |
| Placebo - Part I | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QT Interval, Aggregate, msec | -10.6 msec | Standard Deviation 49.2 |
| Placebo - Part I | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QTcF Interval, Aggregate, msec | -27.5 msec | Standard Deviation 41.79 |
| BMS-986231 - Part I | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QTcF Interval, Aggregate, msec | -13.9 msec | Standard Deviation 41.56 |
| BMS-986231 - Part I | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QRS Duration, Aggregate, msec | -0.1 msec | Standard Deviation 12.46 |
| BMS-986231 - Part I | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | PR Interval, Aggregate, msec | -2.3 msec | Standard Deviation 32.11 |
| BMS-986231 - Part I | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QT Interval, Aggregate, msec | 7.2 msec | Standard Deviation 48.25 |
| Placebo - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | PR Interval, Aggregate, msec | -0.1 msec | Standard Deviation 23.49 |
| Placebo - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QTcF Interval, Aggregate, msec | -4.0 msec | Standard Deviation 51.04 |
| Placebo - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QRS Duration, Aggregate, msec | 1.6 msec | Standard Deviation 20.29 |
| Placebo - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QT Interval, Aggregate, msec | 8.7 msec | Standard Deviation 53.17 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | PR Interval, Aggregate, msec | 10.9 msec | Standard Deviation 22.02 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QRS Duration, Aggregate, msec | -1.6 msec | Standard Deviation 13.22 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QT Interval, Aggregate, msec | 5.8 msec | Standard Deviation 42.19 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QTcF Interval, Aggregate, msec | -4.0 msec | Standard Deviation 33.59 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QTcF Interval, Aggregate, msec | -10.3 msec | Standard Deviation 37.63 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QT Interval, Aggregate, msec | -0.3 msec | Standard Deviation 45.39 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QRS Duration, Aggregate, msec | 2.7 msec | Standard Deviation 16.77 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | PR Interval, Aggregate, msec | 2.0 msec | Standard Deviation 25.41 |
| Placebo - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QTcF Interval, Aggregate, msec | -24.8 msec | Standard Deviation 20 |
| Placebo - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QT Interval, Aggregate, msec | -30.0 msec | Standard Deviation 28.17 |
| Placebo - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QRS Duration, Aggregate, msec | -3.0 msec | Standard Deviation 4.8 |
| Placebo - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | PR Interval, Aggregate, msec | -1.5 msec | Standard Deviation 16.5 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QTcF Interval, Aggregate, msec | -8.8 msec | Standard Deviation 22.35 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | PR Interval, Aggregate, msec | 10.4 msec | Standard Deviation 26.32 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QT Interval, Aggregate, msec | 5.7 msec | Standard Deviation 24.41 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QRS Duration, Aggregate, msec | -2.5 msec | Standard Deviation 7.2 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QRS Duration, Aggregate, msec | 3.0 msec | Standard Deviation 4.38 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QT Interval, Aggregate, msec | 16.5 msec | Standard Deviation 50.22 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | QTcF Interval, Aggregate, msec | 3.2 msec | Standard Deviation 22.93 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration | PR Interval, Aggregate, msec | 6.0 msec | Standard Deviation 30.1 |
Secondary
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)
The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L) | 4.33 µmol/L | Standard Deviation 17.728 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L) | -1.50 µmol/L | Standard Deviation 6.775 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L) | 12.40 µmol/L | Standard Deviation 23.891 |
Secondary
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)
The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L) | 0.18 mg/L | Standard Deviation 0.268 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L) | 0.17 mg/L | Standard Deviation 0.15 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L) | 0.25 mg/L | Standard Deviation 0.077 |
Secondary
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion
The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion | 4.88 Fractional Potassium Excretion percent | Standard Deviation 8.009 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion | -1.22 Fractional Potassium Excretion percent | Standard Deviation 4.926 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion | -12.34 Fractional Potassium Excretion percent | Standard Deviation 13.316 |
Secondary
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion
The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion | 0.02 Fractional Sodium Excretion percent | Standard Deviation 2.076 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion | -2.62 Fractional Sodium Excretion percent | Standard Deviation 4.538 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion | -5.50 Fractional Sodium Excretion percent | Standard Deviation 7.984 |
Secondary
Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)
The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L) | 79.38 nmol/L | Standard Deviation 192.568 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L) | 74.13 nmol/L | Standard Deviation 110.919 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L) | 131.64 nmol/L | Standard Deviation 407.611 |
Secondary
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
Time frame: to 120 hours
Population: All treated participants with a 120-hour evaluation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L | hemoglobin, g/L | -0.67 g/L | Standard Deviation 11.851 |
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L | protein, g/L | 1.10 g/L | Standard Deviation 6.172 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L | hemoglobin, g/L | -0.70 g/L | Standard Deviation 8.573 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L | protein, g/L | 2.77 g/L | Standard Deviation 5.839 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L | hemoglobin, g/L | 1.20 g/L | Standard Deviation 11.487 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L | protein, g/L | 0.57 g/L | Standard Deviation 8.178 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L | protein, g/L | 0.38 g/L | Standard Deviation 6.048 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L | hemoglobin, g/L | 0.94 g/L | Standard Deviation 11.684 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L | hemoglobin, g/L | 1.38 g/L | Standard Deviation 9.161 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L | protein, g/L | -0.05 g/L | Standard Deviation 5.367 |
Secondary
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL | NA mg/dL |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL | NA mg/dL |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL | NA mg/dL |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL | NA mg/dL |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL | NA mg/dL |
Secondary
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | blood urea nitrogen, mmol/L | 4.01 mmol/L | Standard Deviation 5.474 |
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | potassium, mmol/L | 0.19 mmol/L | Standard Deviation 0.697 |
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | urate, mmol/L | 0.06 mmol/L | Standard Deviation 0.154 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | urate, mmol/L | 0.01 mmol/L | Standard Deviation 0.108 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | blood urea nitrogen, mmol/L | 0.32 mmol/L | Standard Deviation 3.164 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | potassium, mmol/L | 0.28 mmol/L | Standard Deviation 0.513 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | urate, mmol/L | -0.01 mmol/L | Standard Deviation 0.126 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | blood urea nitrogen, mmol/L | 1.96 mmol/L | Standard Deviation 3.92 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | potassium, mmol/L | 0.21 mmol/L | Standard Deviation 0.692 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | blood urea nitrogen, mmol/L | 2.15 mmol/L | Standard Deviation 5.016 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | potassium, mmol/L | 0.13 mmol/L | Standard Deviation 0.558 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | urate, mmol/L | 0.04 mmol/L | Standard Deviation 0.147 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | urate, mmol/L | -0.03 mmol/L | Standard Deviation 0.111 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | blood urea nitrogen, mmol/L | 1.24 mmol/L | Standard Deviation 3.655 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L | potassium, mmol/L | 0.15 mmol/L | Standard Deviation 0.651 |
Secondary
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | alanine aminotransferase (ALT), U/L | 148.13 U/L | Standard Deviation 837.833 |
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | asparate aminotransferase, U/L | 214.77 U/L | Standard Deviation 1204.41 |
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | alkaline phosphatase, U/L | -1.00 U/L | Standard Deviation 28.018 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | alkaline phosphatase, U/L | 1.65 U/L | Standard Deviation 11.052 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | alanine aminotransferase (ALT), U/L | -2.73 U/L | Standard Deviation 11.089 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | asparate aminotransferase, U/L | -2.77 U/L | Standard Deviation 10.277 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | alkaline phosphatase, U/L | -1.31 U/L | Standard Deviation 25.186 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | alanine aminotransferase (ALT), U/L | -3.22 U/L | Standard Deviation 102.038 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | asparate aminotransferase, U/L | -11.15 U/L | Standard Deviation 127.903 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | alanine aminotransferase (ALT), U/L | 30.36 U/L | Standard Deviation 189.31 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | asparate aminotransferase, U/L | 10.81 U/L | Standard Deviation 65.009 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | alkaline phosphatase, U/L | 5.43 U/L | Standard Deviation 26.007 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | alkaline phosphatase, U/L | -0.49 U/L | Standard Deviation 21.474 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | alanine aminotransferase (ALT), U/L | -13.07 U/L | Standard Deviation 76.357 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L | asparate aminotransferase, U/L | -10.00 U/L | Standard Deviation 52.075 |
Secondary
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L | -0.02 x10^12 c/L | Standard Deviation 0.394 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L | 0.02 x10^12 c/L | Standard Deviation 0.305 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L | 0.04 x10^12 c/L | Standard Deviation 0.409 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L | 0.04 x10^12 c/L | Standard Deviation 0.481 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L | 0.09 x10^12 c/L | Standard Deviation 0.337 |
Secondary
Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L
The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.
Time frame: to 120 hours
Population: All treated participants with a 120-hour evaluation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L | leukocyte, x10^9 c/L | 0.12 x10^9 cells/L | Standard Deviation 3.078 |
| Placebo - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L | platelet, x10^9 c/L | 5.63 x10^9 cells/L | Standard Deviation 31.679 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L | leukocyte, x10^9 c/L | -1.38 x10^9 cells/L | Standard Deviation 1.892 |
| BMS-986231 - Part I | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L | platelet, x10^9 c/L | -5.77 x10^9 cells/L | Standard Deviation 34.666 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L | leukocyte, x10^9 c/L | -0.20 x10^9 cells/L | Standard Deviation 4.37 |
| Placebo - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L | platelet, x10^9 c/L | 1.84 x10^9 cells/L | Standard Deviation 40.808 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L | platelet, x10^9 c/L | 3.26 x10^9 cells/L | Standard Deviation 37.888 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L | leukocyte, x10^9 c/L | 0.20 x10^9 cells/L | Standard Deviation 2.549 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L | leukocyte, x10^9 c/L | -0.09 x10^9 cells/L | Standard Deviation 1.98 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L | platelet, x10^9 c/L | 1.26 x10^9 cells/L | Standard Deviation 31.135 |
Secondary
Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32
Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide)
Time frame: 0, 24, 48, 72, 120 hour or discharge; Day 32
Population: All treated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Part I | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 120 hour | -541.36 pmol/L | Standard Deviation 773.006 |
| Placebo - Part I | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 48 hour | -405.06 pmol/L | Standard Deviation 591.711 |
| Placebo - Part I | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 24 hour | -270.88 pmol/L | Standard Deviation 400.32 |
| Placebo - Part I | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 72 hour | -396.21 pmol/L | Standard Deviation 675.761 |
| Placebo - Part I | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | Day 32 | -202.07 pmol/L | Standard Deviation 799.169 |
| BMS-986231 - Part I | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 24 hour | -364.46 pmol/L | Standard Deviation 456.158 |
| BMS-986231 - Part I | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 120 hour | -409.53 pmol/L | Standard Deviation 751.624 |
| BMS-986231 - Part I | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 72 hour | -373.86 pmol/L | Standard Deviation 702.53 |
| BMS-986231 - Part I | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 48 hour | -510.51 pmol/L | Standard Deviation 592.734 |
| BMS-986231 - Part I | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | Day 32 | -91.61 pmol/L | Standard Deviation 2254.397 |
| Placebo - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 24 hour | -147.96 pmol/L | Standard Deviation 452.239 |
| Placebo - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | Day 32 | -321.73 pmol/L | Standard Deviation 600.297 |
| Placebo - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 72 hour | -249.26 pmol/L | Standard Deviation 655.999 |
| Placebo - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 48 hour | -210.87 pmol/L | Standard Deviation 580.487 |
| Placebo - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 120 hour | -140.60 pmol/L | Standard Deviation 1358.127 |
| BMS-986231 6 µg/kg/Min - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 24 hour | -340.74 pmol/L | Standard Deviation 430.639 |
| BMS-986231 6 µg/kg/Min - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 48 hour | -300.87 pmol/L | Standard Deviation 725.268 |
| BMS-986231 6 µg/kg/Min - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | Day 32 | -361.73 pmol/L | Standard Deviation 782.881 |
| BMS-986231 6 µg/kg/Min - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 120 hour | -76.20 pmol/L | Standard Deviation 993.11 |
| BMS-986231 6 µg/kg/Min - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 72 hour | -118.86 pmol/L | Standard Deviation 900.798 |
| BMS-986231 12 µg/kg/Min - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 120 hour | -390.21 pmol/L | Standard Deviation 717.114 |
| BMS-986231 12 µg/kg/Min - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | Day 32 | -476.86 pmol/L | Standard Deviation 716.072 |
| BMS-986231 12 µg/kg/Min - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 72 hour | -293.94 pmol/L | Standard Deviation 685.681 |
| BMS-986231 12 µg/kg/Min - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 24 hour | -416.91 pmol/L | Standard Deviation 503.825 |
| BMS-986231 12 µg/kg/Min - Part II | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 48 hour | -472.32 pmol/L | Standard Deviation 610.59 |
| Placebo - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 72 hour | -433.08 pmol/L | Standard Deviation 761.573 |
| Placebo - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 48 hour | -329.24 pmol/L | Standard Deviation 646.985 |
| Placebo - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | Day 32 | -556.69 pmol/L | Standard Deviation 1288.342 |
| Placebo - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 120 hour | -434.36 pmol/L | Standard Deviation 659.528 |
| Placebo - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 24 hour | -129.70 pmol/L | Standard Deviation 255.716 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 120 hour | -379.06 pmol/L | Standard Deviation 244.917 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 24 hour | -165.93 pmol/L | Standard Deviation 185.91 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 72 hour | 9.89 pmol/L | Standard Deviation 523.754 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | Day 32 | -343.64 pmol/L | Standard Deviation 377.59 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 48 hour | -251.73 pmol/L | Standard Deviation 243.794 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 72 hour | -229.56 pmol/L | Standard Deviation 809.85 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 48 hour | -497.35 pmol/L | Standard Deviation 725.286 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 24 hour | -397.60 pmol/L | Standard Deviation 330.721 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | 120 hour | -552.55 pmol/L | Standard Deviation 824.009 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32 | Day 32 | -706.11 pmol/L | Standard Deviation 1111.877 |
Secondary
Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72
Endpoint was measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24, 48, and 72. Participants were asked to report their absolute current severity of dyspnea on an 11-point numerical rating scale (NRS; range 0 to 10). The numerical rating scale (NRS) was used to assess the degree of dyspnea (breathlessness), measured using an 11-point scale provided by the Sponsor. A score of 0 represents I am not breathless at all and 10 represents I am the most breathless I can possibly imagine.
Time frame: Hours 6, 12, 24, 48, and 72
Population: All treated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Part I | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 6 hour | -1.5 Scores on a scale | Standard Deviation 1.84 |
| Placebo - Part I | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 48 hour | -2.8 Scores on a scale | Standard Deviation 2.15 |
| Placebo - Part I | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 24 hour | -2.0 Scores on a scale | Standard Deviation 2.5 |
| Placebo - Part I | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 72 hour | -2.9 Scores on a scale | Standard Deviation 2.23 |
| Placebo - Part I | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 12 hour | -2.1 Scores on a scale | Standard Deviation 2.38 |
| BMS-986231 - Part I | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 72 hour | -3.7 Scores on a scale | Standard Deviation 2.22 |
| BMS-986231 - Part I | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 6 hour | -1.5 Scores on a scale | Standard Deviation 1.64 |
| BMS-986231 - Part I | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 48 hour | -2.6 Scores on a scale | Standard Deviation 2.51 |
| BMS-986231 - Part I | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 12 hour | -2.2 Scores on a scale | Standard Deviation 1.73 |
| BMS-986231 - Part I | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 24 hour | -2.1 Scores on a scale | Standard Deviation 2.19 |
| Placebo - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 48 hour | -2.8 Scores on a scale | Standard Deviation 3 |
| Placebo - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 72 hour | -3.2 Scores on a scale | Standard Deviation 3.19 |
| Placebo - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 6 hour | -1.1 Scores on a scale | Standard Deviation 1.9 |
| Placebo - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 24 hour | -2.1 Scores on a scale | Standard Deviation 2.82 |
| Placebo - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 12 hour | -1.7 Scores on a scale | Standard Deviation 2.75 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 48 hour | -3.4 Scores on a scale | Standard Deviation 2.44 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 72 hour | -3.9 Scores on a scale | Standard Deviation 2.28 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 12 hour | -2.4 Scores on a scale | Standard Deviation 2.38 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 6 hour | -1.7 Scores on a scale | Standard Deviation 1.94 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 24 hour | -2.9 Scores on a scale | Standard Deviation 2.68 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 24 hour | -2.2 Scores on a scale | Standard Deviation 2.42 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 6 hour | -1.7 Scores on a scale | Standard Deviation 2.13 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 12 hour | -2.0 Scores on a scale | Standard Deviation 2.49 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 48 hour | -2.8 Scores on a scale | Standard Deviation 2.45 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 72 hour | -3.2 Scores on a scale | Standard Deviation 2.73 |
| Placebo - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 24 hour | -0.8 Scores on a scale | Standard Deviation 1.72 |
| Placebo - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 48 hour | -1.2 Scores on a scale | Standard Deviation 1.47 |
| Placebo - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 6 hour | -0.3 Scores on a scale | Standard Deviation 1.03 |
| Placebo - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 12 hour | -1.0 Scores on a scale | Standard Deviation 1.79 |
| Placebo - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 72 hour | -1.2 Scores on a scale | Standard Deviation 2.14 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 24 hour | -1.5 Scores on a scale | Standard Deviation 3.02 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 12 hour | -0.2 Scores on a scale | Standard Deviation 3.37 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 6 hour | 0.0 Scores on a scale | Standard Deviation 2.9 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 72 hour | -1.2 Scores on a scale | Standard Deviation 3.19 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 48 hour | -0.8 Scores on a scale | Standard Deviation 3.43 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 72 hour | -2.0 Scores on a scale | Standard Deviation 2 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 48 hour | -2.0 Scores on a scale | Standard Deviation 1.67 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 12 hour | -1.4 Scores on a scale | Standard Deviation 4.22 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 24 hour | -1.2 Scores on a scale | Standard Deviation 2.14 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72 | 6 hour | -1.3 Scores on a scale | Standard Deviation 3.44 |
Secondary
Change in Physical Measurements From Baseline to 120 Hours
The change in baseline for physical measurements was reported for each arm.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part I | Change in Physical Measurements From Baseline to 120 Hours | 0.00 kg | Standard Deviation 383 |
| BMS-986231 - Part I | Change in Physical Measurements From Baseline to 120 Hours | 0.10 kg | Standard Deviation 0.285 |
| Placebo - Part II | Change in Physical Measurements From Baseline to 120 Hours | -2.87 kg | Standard Deviation 4.447 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Physical Measurements From Baseline to 120 Hours | -2.96 kg | Standard Deviation 4.231 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Physical Measurements From Baseline to 120 Hours | -1.83 kg | Standard Deviation 5.295 |
| Placebo - Part II (Japan Cohort) | Change in Physical Measurements From Baseline to 120 Hours | -3.58 kg | Standard Deviation 2.182 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Physical Measurements From Baseline to 120 Hours | -3.97 kg | Standard Deviation 2.16 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Physical Measurements From Baseline to 120 Hours | -6.08 kg | Standard Deviation 4.009 |
Secondary
Change in Troponin T From Baseline to Hour 24, 48, and 72
Baseline = Last non-missing result with a collection date-time less than or on the date-time of the start of infusion of study drug
Time frame: from baseline to Hour 24, 48, and 72
Population: All treated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Part I | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 24 hour | 4.11 ng/L | Standard Deviation 27.303 |
| Placebo - Part I | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 72 hour | 6.07 ng/L | Standard Deviation 30.033 |
| Placebo - Part I | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 48 hour | -0.93 ng/L | Standard Deviation 22.714 |
| BMS-986231 - Part I | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 72 hour | 6.76 ng/L | Standard Deviation 66.673 |
| BMS-986231 - Part I | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 24 hour | -1.31 ng/L | Standard Deviation 12.278 |
| BMS-986231 - Part I | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 48 hour | 14.56 ng/L | Standard Deviation 81.979 |
| Placebo - Part II | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 72 hour | -1.44 ng/L | Standard Deviation 16.472 |
| Placebo - Part II | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 24 hour | -1.80 ng/L | Standard Deviation 11.266 |
| Placebo - Part II | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 48 hour | -2.88 ng/L | Standard Deviation 16.424 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 48 hour | 8.08 ng/L | Standard Deviation 71.672 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 24 hour | -3.45 ng/L | Standard Deviation 20.03 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 72 hour | 5.00 ng/L | Standard Deviation 65.766 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 72 hour | -13.05 ng/L | Standard Deviation 68.276 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 48 hour | -11.15 ng/L | Standard Deviation 45.495 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 24 hour | -8.09 ng/L | Standard Deviation 37.864 |
| Placebo - Part II (Japan Cohort) | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 48 hour | -10.67 ng/L | Standard Deviation 10.633 |
| Placebo - Part II (Japan Cohort) | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 72 hour | -10.50 ng/L | Standard Deviation 12.145 |
| Placebo - Part II (Japan Cohort) | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 24 hour | -4.67 ng/L | Standard Deviation 3.983 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 72 hour | 248.00 ng/L | Standard Deviation 433.581 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 24 hour | 1.33 ng/L | Standard Deviation 5.75 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 48 hour | 49.50 ng/L | Standard Deviation 118.417 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 48 hour | -8.40 ng/L | Standard Deviation 25.501 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 24 hour | -7.67 ng/L | Standard Deviation 16.669 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Troponin T From Baseline to Hour 24, 48, and 72 | 72 hour | -15.00 ng/L | Standard Deviation 25.169 |
Secondary
Change in Vital Signs From Baseline to 120 Hours - Blood Pressure
The change in baseline for vital signs was reported for each arm.
Time frame: to 120 hours
Population: All treated participants with a 120-hour evaluation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo - Part I | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | systolic blood pressure, mmHg | -6.8 mmHg | Standard Deviation 16.6 |
| Placebo - Part I | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | diastolic blood pressure, mmHg | -4.0 mmHg | Standard Deviation 12.67 |
| BMS-986231 - Part I | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | systolic blood pressure, mmHg | 0.0 mmHg | Standard Deviation 17.75 |
| BMS-986231 - Part I | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | diastolic blood pressure, mmHg | -1.9 mmHg | Standard Deviation 13.53 |
| Placebo - Part II | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | systolic blood pressure, mmHg | -4.3 mmHg | Standard Deviation 15.23 |
| Placebo - Part II | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | diastolic blood pressure, mmHg | -4.4 mmHg | Standard Deviation 12.99 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | systolic blood pressure, mmHg | -7.9 mmHg | Standard Deviation 15.6 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | diastolic blood pressure, mmHg | -3.4 mmHg | Standard Deviation 14.37 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | systolic blood pressure, mmHg | -8.8 mmHg | Standard Deviation 14.01 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | diastolic blood pressure, mmHg | -1.6 mmHg | Standard Deviation 10.83 |
| Placebo - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | systolic blood pressure, mmHg | -10.3 mmHg | Standard Deviation 15.6 |
| Placebo - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | diastolic blood pressure, mmHg | 1.7 mmHg | Standard Deviation 16.24 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | diastolic blood pressure, mmHg | -15.7 mmHg | Standard Deviation 19.08 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | systolic blood pressure, mmHg | -17.5 mmHg | Standard Deviation 9.14 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | systolic blood pressure, mmHg | -6.2 mmHg | Standard Deviation 16.44 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Blood Pressure | diastolic blood pressure, mmHg | -9.3 mmHg | Standard Deviation 14.45 |
Secondary
Change in Vital Signs From Baseline to 120 Hours - Heart Rate
The change in baseline for vital signs was reported for each arm.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part I | Change in Vital Signs From Baseline to 120 Hours - Heart Rate | -1.8 beats/min | Standard Deviation 15.53 |
| BMS-986231 - Part I | Change in Vital Signs From Baseline to 120 Hours - Heart Rate | -9.1 beats/min | Standard Deviation 17.13 |
| Placebo - Part II | Change in Vital Signs From Baseline to 120 Hours - Heart Rate | -8.3 beats/min | Standard Deviation 15.55 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Vital Signs From Baseline to 120 Hours - Heart Rate | -4.6 beats/min | Standard Deviation 15.4 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Vital Signs From Baseline to 120 Hours - Heart Rate | -6.3 beats/min | Standard Deviation 15.6 |
| Placebo - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Heart Rate | -6.7 beats/min | Standard Deviation 21.88 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Heart Rate | -3.0 beats/min | Standard Deviation 13.31 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Heart Rate | 3.8 beats/min | Standard Deviation 11.55 |
Secondary
Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate
The change in baseline for vital signs was reported for each arm.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part I | Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate | -2.6 breaths/min | Standard Deviation 3.93 |
| BMS-986231 - Part I | Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate | -3.0 breaths/min | Standard Deviation 4.82 |
| Placebo - Part II | Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate | -2.9 breaths/min | Standard Deviation 3.8 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate | -2.6 breaths/min | Standard Deviation 4.33 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate | -1.8 breaths/min | Standard Deviation 3.96 |
| Placebo - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate | -2.3 breaths/min | Standard Deviation 2.88 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate | 0.0 breaths/min | Standard Deviation 9.98 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate | -1.4 breaths/min | Standard Deviation 3.58 |
Secondary
Change in Vital Signs From Baseline to 120 Hours - Temperature
The change in baseline for vital signs was reported for each arm.
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Part I | Change in Vital Signs From Baseline to 120 Hours - Temperature | -0.04 degrees C | Standard Deviation 0.643 |
| BMS-986231 - Part I | Change in Vital Signs From Baseline to 120 Hours - Temperature | 0.09 degrees C | Standard Deviation 0.649 |
| Placebo - Part II | Change in Vital Signs From Baseline to 120 Hours - Temperature | 0.04 degrees C | Standard Deviation 0.427 |
| BMS-986231 6 µg/kg/Min - Part II | Change in Vital Signs From Baseline to 120 Hours - Temperature | 0.00 degrees C | Standard Deviation 0.342 |
| BMS-986231 12 µg/kg/Min - Part II | Change in Vital Signs From Baseline to 120 Hours - Temperature | -0.05 degrees C | Standard Deviation 0.481 |
| Placebo - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Temperature | -0.47 degrees C | Standard Deviation 0.65 |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Temperature | -0.27 degrees C | Standard Deviation 0.535 |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Change in Vital Signs From Baseline to 120 Hours - Temperature | 0.44 degrees C | Standard Deviation 0.541 |
Secondary
Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182
Number of participants who died (all- cause and CV related) through Day 182. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 CV=Cardiovascular
Time frame: through 182 days
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Part I | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | All-cause | 3 Participants |
| Placebo - Part I | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | CV-related | 3 Participants |
| BMS-986231 - Part I | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | All-cause | 3 Participants |
| BMS-986231 - Part I | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | CV-related | 2 Participants |
| Placebo - Part II | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | All-cause | 11 Participants |
| Placebo - Part II | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | CV-related | 9 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | All-cause | 12 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | CV-related | 10 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | All-cause | 9 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | CV-related | 4 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | All-cause | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | CV-related | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | CV-related | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | All-cause | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | All-cause | 1 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182 | CV-related | 0 Participants |
Secondary
Number of Participants Who Discontinued Due to Hypotension
Number of participants who discontinued study treatment due to hypotension. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. Hypotension defined as systolic blood pressure (SBP) \< 90 mmHg.
Time frame: up to 120 hours (for AEs); up to 32 days (for SAEs)
Population: All treated participants~Note: Discontinuation due to hypotension occurred per protocol-mandated lowering of blood pressure to \< 90 mmHg.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo - Part I | Number of Participants Who Discontinued Due to Hypotension | 4 Participants |
| BMS-986231 - Part I | Number of Participants Who Discontinued Due to Hypotension | 8 Participants |
| Placebo - Part II | Number of Participants Who Discontinued Due to Hypotension | 7 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants Who Discontinued Due to Hypotension | 13 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants Who Discontinued Due to Hypotension | 16 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants Who Discontinued Due to Hypotension | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Discontinued Due to Hypotension | 1 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Discontinued Due to Hypotension | 3 Participants |
Secondary
Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure
Number of participants who discontinued study treatment, experienced a down-titration (dose reduction) or dose interruption due to decreased blood pressure/hypotension are reported below. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment. If the participant experienced systolic blood pressure (SBP) \< 95 mm Hg, without symptoms related to hypotension, the measurement was repeated within 15 minutes. If the SBP remained \< 95 mm Hg, the dose reduction occurred.
Time frame: up to 120 hours (for AEs); up to 32 days (for SAEs)
Population: All treated participants~Note: Discontinuation due to decreased blood pressure occurred per protocol-mandated lowering of blood pressure to \< 95 mmHg.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Part I | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | discontinuation | 4 Participants |
| Placebo - Part I | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | interruption | 3 Participants |
| Placebo - Part I | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | down-titration | 3 Participants |
| BMS-986231 - Part I | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | down-titration | 9 Participants |
| BMS-986231 - Part I | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | discontinuation | 8 Participants |
| BMS-986231 - Part I | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | interruption | 4 Participants |
| Placebo - Part II | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | interruption | 4 Participants |
| Placebo - Part II | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | down-titration | 9 Participants |
| Placebo - Part II | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | discontinuation | 7 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | discontinuation | 13 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | down-titration | 10 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | interruption | 12 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | down-titration | 25 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | interruption | 13 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | discontinuation | 15 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | interruption | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | down-titration | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | discontinuation | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | discontinuation | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | down-titration | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | interruption | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | discontinuation | 3 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | down-titration | 3 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure | interruption | 0 Participants |
Secondary
Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours
Number of participants who experienced an in-study AE. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment.
Time frame: up to 120 hours
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo - Part I | Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours | 31 Participants |
| BMS-986231 - Part I | Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours | 39 Participants |
| Placebo - Part II | Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours | 48 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours | 48 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours | 55 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours | 2 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours | 6 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours | 6 Participants |
Secondary
Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32
Number of participants who experienced an in-study SAE. Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.
Time frame: 32 days
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo - Part I | Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32 | 11 Participants |
| BMS-986231 - Part I | Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32 | 14 Participants |
| Placebo - Part II | Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32 | 23 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32 | 15 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32 | 15 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32 | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32 | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32 | 1 Participants |
Secondary
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry
Number of participants who experienced an in-study Chemistry marked laboratory abnormality (reported in \> 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high potassium values | 2 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high asparate aminotransferase values | 4 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alkaline phosphatase values | 5 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high sodium values | 0 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low sodium values | 0 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high blood urea nitrogen values | 23 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high creatine kinase values | 0 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low bicarbonate values | 0 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alanine aminotransferase (ALT) values | 6 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high urate values | 10 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low calcium values | 0 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low protein values | 3 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bicarbonate values | 1 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low chloride counts | 1 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low albumin values | 0 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high protein values | 1 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bilirubin values | 2 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high asparate aminotransferase values | 0 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bicarbonate values | 2 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bilirubin values | 2 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high urate values | 15 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high blood urea nitrogen values | 16 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low albumin values | 0 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low sodium values | 0 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high potassium values | 5 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low bicarbonate values | 0 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alanine aminotransferase (ALT) values | 1 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high sodium values | 1 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alkaline phosphatase values | 0 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high protein values | 0 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high creatine kinase values | 1 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low protein values | 9 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low calcium values | 0 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low chloride counts | 2 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low albumin values | 0 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alkaline phosphatase values | 2 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low calcium values | 2 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low chloride counts | 1 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low sodium values | 0 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high creatine kinase values | 0 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high asparate aminotransferase values | 4 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high urate values | 10 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bilirubin values | 0 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low protein values | 3 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alanine aminotransferase (ALT) values | 5 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low bicarbonate values | 2 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high sodium values | 2 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bicarbonate values | 0 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high blood urea nitrogen values | 23 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high protein values | 2 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high potassium values | 6 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bicarbonate values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high blood urea nitrogen values | 23 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high urate values | 20 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high potassium values | 7 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alanine aminotransferase (ALT) values | 2 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alkaline phosphatase values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low protein values | 8 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high asparate aminotransferase values | 2 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bilirubin values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low albumin values | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low chloride counts | 4 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high creatine kinase values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high protein values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high sodium values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low bicarbonate values | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low sodium values | 2 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low calcium values | 1 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high creatine kinase values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bilirubin values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alanine aminotransferase (ALT) values | 2 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high protein values | 2 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low albumin values | 2 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alkaline phosphatase values | 1 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high urate values | 8 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bicarbonate values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low sodium values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low chloride counts | 1 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high asparate aminotransferase values | 1 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high potassium values | 2 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low bicarbonate values | 1 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low protein values | 4 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high sodium values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low calcium values | 2 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high blood urea nitrogen values | 18 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high blood urea nitrogen values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bicarbonate values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low protein values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low chloride counts | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high creatine kinase values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alkaline phosphatase values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high protein values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alanine aminotransferase (ALT) values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high sodium values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high potassium values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low calcium values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low bicarbonate values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low sodium values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high urate values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low albumin values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bilirubin values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high asparate aminotransferase values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low sodium values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bicarbonate values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low bicarbonate values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low protein values | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high potassium values | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low chloride counts | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high sodium values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high urate values | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low calcium values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high asparate aminotransferase values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high protein values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high blood urea nitrogen values | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alanine aminotransferase (ALT) values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low albumin values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high creatine kinase values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alkaline phosphatase values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bilirubin values | 1 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alkaline phosphatase values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high sodium values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high potassium values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low albumin values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bicarbonate values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low chloride counts | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low bicarbonate values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high urate values | 1 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low sodium values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high bilirubin values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high blood urea nitrogen values | 2 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low protein values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high alanine aminotransferase (ALT) values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | low calcium values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high creatine kinase values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high protein values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry | high asparate aminotransferase values | 0 Participants |
Secondary
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology
Number of participants who experienced an in-study Hematology marked laboratory abnormality (reported in \> 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low erythrocytes values | 1 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low leukocyte counts | 0 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hemoglobin values | 4 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low neutrophils values | 0 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | high leukocyte counts | 5 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hematocrit values | 1 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low platelet values | 4 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hemoglobin values | 5 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low neutrophils values | 1 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low erythrocytes values | 1 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | high leukocyte counts | 2 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hematocrit values | 1 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low leukocyte counts | 1 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low platelet values | 2 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low erythrocytes values | 1 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low leukocyte counts | 2 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low platelet values | 2 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hematocrit values | 1 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hemoglobin values | 5 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low neutrophils values | 1 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | high leukocyte counts | 5 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low leukocyte counts | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | high leukocyte counts | 4 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hemoglobin values | 6 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low platelet values | 7 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low neutrophils values | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hematocrit values | 3 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low erythrocytes values | 3 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low neutrophils values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low leukocyte counts | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low erythrocytes values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | high leukocyte counts | 3 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low platelet values | 1 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hematocrit values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hemoglobin values | 4 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low erythrocytes values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low neutrophils values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low leukocyte counts | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hemoglobin values | 1 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hematocrit values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | high leukocyte counts | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low platelet values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hemoglobin values | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low erythrocytes values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hematocrit values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | high leukocyte counts | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low platelet values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low leukocyte counts | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low neutrophils values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low leukocyte counts | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low neutrophils values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hemoglobin values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low platelet values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low erythrocytes values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | low hematocrit values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology | high leukocyte counts | 0 Participants |
Secondary
Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis
Number of participants who experienced an in-study Urinalysis marked laboratory abnormality (reported in \> 5% of total participants). Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0
Time frame: to 120 hours
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high protein values | 10 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high leukocytes values | 0 Participants |
| Placebo - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high erythrocyte values | 1 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high leukocytes values | 1 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high erythrocyte values | 1 Participants |
| BMS-986231 - Part I | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high protein values | 11 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high leukocytes values | 0 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high protein values | 16 Participants |
| Placebo - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high erythrocyte values | 1 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high protein values | 13 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high erythrocyte values | 3 Participants |
| BMS-986231 6 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high leukocytes values | 2 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high erythrocyte values | 2 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high protein values | 17 Participants |
| BMS-986231 12 µg/kg/Min - Part II | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high leukocytes values | 1 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high erythrocyte values | 0 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high protein values | 2 Participants |
| Placebo - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high leukocytes values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high erythrocyte values | 0 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high protein values | 2 Participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high leukocytes values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high protein values | 2 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high erythrocyte values | 0 Participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis | high leukocytes values | 0 Participants |
Secondary
Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value)
The percentage of participants experiencing SBP \< 90 mm Hg (confirmed by a repeated value) up to 6 hours post-treatment was reported for each arm.
Time frame: From start of infusion up to 6 hours post end of infusion
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo - Part I | Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value) | 6.3 Percentage of participants |
| BMS-986231 - Part I | Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value) | 20.4 Percentage of participants |
| Placebo - Part II | Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value) | 18.3 Percentage of participants |
| BMS-986231 6 µg/kg/Min - Part II | Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value) | 21.1 Percentage of participants |
| BMS-986231 12 µg/kg/Min - Part II | Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value) | 29.2 Percentage of participants |
| Placebo - Part II (Japan Cohort) | Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value) | 0 Percentage of participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value) | 33.3 Percentage of participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value) | 50.0 Percentage of participants |
95% CI: [1.01, 14.66]
95% CI: [0, 0.29]
95% CI: [0.58, 2.43]
95% CI: [-0.11, 0.16]
95% CI: [0.87, 3.21]
95% CI: [-0.04, 0.25]
95% CI: [-0.17, 0.78]
95% CI: [-0.04, 0.88]
Secondary
Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion
The percentage of participants experiencing symptoms of hypotension up to 6 hours post-treatment was reported for each arm.
Time frame: From start of infusion up to 6 hours post end of infusion
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo - Part I | Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion | 2.1 Percentage of participants |
| BMS-986231 - Part I | Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion | 6.1 Percentage of participants |
| Placebo - Part II | Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion | 1.4 Percentage of participants |
| BMS-986231 6 µg/kg/Min - Part II | Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion | 2.8 Percentage of participants |
| BMS-986231 12 µg/kg/Min - Part II | Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion | 8.3 Percentage of participants |
| Placebo - Part II (Japan Cohort) | Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion | 0 Percentage of participants |
| BMS-986231 6 µg/kg/Min - Part II (Japan Cohort) | Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion | 0 Percentage of participants |
| BMS-986231 12 µg/kg/Min - Part II (Japan Cohort) | Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion | 0 Percentage of participants |
95% CI: [0.31, 75.47]
95% CI: [-0.06, 0.15]
95% CI: [0.18, 54.35]
95% CI: [-0.05, 0.09]
95% CI: [0.91, 149.72]
95% CI: [-0.01, 0.16]