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The purpose of this study is to evaluate the effect of BMS-986278 on the cardiac repolarization in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
| |
| Treatment B | Experimental |
| |
| Treatment C | Placebo Comparator |
| |
| Treatment D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986278 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF) | Up to Day 13 | |
| Placebo-corrected change from baseline QTcF (ΔΔQTcF) | Up to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline heart rate (HR) | Up to Day 13 | |
| Placebo-corrected change from baseline HR | Up to Day 13 | |
| Change from baseline PR interval |
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Inclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials | Recruiting | San Antonio | Texas | 78217 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo |
| Drug |
Specified dose on specified days |
|
| Moxifloxacin | Drug | Specified dose on specified days |
|
| Up to Day 13 |
| Placebo-corrected change from baseline PR interval | Up to Day 13 |
| Change from baseline QRS interval | Up to Day 13 |
| Placebo-corrected change from baseline QRS interval | Up to Day 13 |
| Number of participants with categorical outliers for QTcF | Up to Day 13 |
| Number of participants with categorical outliers for HR | Up to Day 13 |
| Number of participants with categorical outliers for PR interval | Up to Day 13 |
| Number of participants with categorical outliers for QRS interval | Up to Day 13 |
| Number of participants with treatment-emergent changes of electrocardiogram (ECG) morphology | Up to Day 13 |
| Change from baseline QTcF (ΔQTcF) | Up to Day 13 |
| Placebo-corrected change from baseline QTcF (ΔΔQTcF) | Up to Day 13 |
| Number of participants with non-serious adverse events (AEs) | Up to approximately 17 weeks |
| Number of participants with Serious AEs (SAEs) | Up to approximately 17 weeks |
| Number of participants with AEs leading to study intervention discontinuation | Up to approximately 17 weeks |
| Number of participants with vital sign abnormalities | Up to approximately 17 weeks |
| Number of participants with clinical laboratory assessment abnormalities | Up to approximately 17 weeks |
| Number of participants with 12-lead ECG abnormalities | Up to approximately 17 weeks |
| Number of participants with physical examination abnormalities | Up to approximately 17 weeks |
| Maximum observed concentration (Cmax) | Up to Day 13 |
| Time of maximum observed concentration (Tmax) | Up to Day 13 |
| Area under the concentration-time curve in 1 dosing interval (AUC[TAU]) | Up to Day 13 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |