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The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of high dose of BMS-986278 in healthy participants and to assess the effect of BMS-986278 on the ECG intervals in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental |
| |
| Part B1/B2 Treatment A | Experimental |
| |
| Part B1/B2 Treatment B | Experimental |
| |
| Part B1/B2 Treatment C | Experimental |
| |
| Part B1/B2 Treatment D | Experimental |
| |
| Part B3 Treatment A | Experimental |
| |
| Part B3 Treatment B | Experimental |
| |
| Part B3 Treatment C |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986278 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with non-serious Adverse Events (AEs) | Part A | Until 28 days post last treatment dose |
| Number of participants with Serious AEs (SAEs) | Part A | Until 28 days post last treatment dose |
| Number of participants with AEs leading to study intervention discontinuation | Part A | Until 28 days post last treatment dose |
| Number of participants with vital sign abnormalities | Part A | Up to Day 18 |
| Number of participants with clinical laboratory assessment abnormalities | Part A | Up to Day 18 |
| Number of participants with 12-lead electrocardiogram (ECG) abnormalities | Part A | Up to Day 18 |
| Number of participants with physical examination abnormalities | Part A | Up to Day 18 |
| Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF) | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Part A and Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Time of maximum observed plasma concentration (Tmax) | Part A and Part B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON San Antonio | San Antonio | Texas | 78209 | United States | ||
| Local Institution - 0001 |
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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/disclosurecommitment.html
See Plan Description
See Plan Description
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Part A, a parallel model, will be followed by Part B, a 4-way crossover model.
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This is a double-blind study, with an open-label positive control in Part B.
| Experimental |
|
| Part B3 Treatment D | Experimental |
|
| Placebo | Drug | Specified dose on specified days |
|
| Moxifloxacin | Drug | Specified dose on specified days |
|
| Placebo-corrected change from baseline QTcF (ΔΔQTcF) |
Part B |
| Up to Day 13 of Period 4 (Each period is 17 days) |
| Up to Day 13 of Period 4 (Each period is 17 days) |
| Area under the plasma concentration-time curve from time zero to the end of dosing interval AUC(TAU) | Part A and Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Terminal half-life (T-HALF) | Part A | Up to Day 18 |
| Apparent total body clearance (CLT/F) | Part A | Up to Day 18 |
| Change from baseline heart rate (HR) (∆HR) | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Change from baseline PR interval (∆PR) | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Change from baseline QRS interval (∆QRS) | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Placebo-corrected change from baseline HR (ΔΔHR) | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Placebo-corrected Change from baseline PR interval (ΔΔPR) | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Placebo-corrected change from baseline QRS interval (ΔΔQRS) | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Number of participants with categorical outliers for QTcF | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Number of participants with categorical outliers for HR | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Number of participants with categorical outliers for PR interval | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Number of participants with categorical outliers for QRS interval | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Number of participants with treatment-emergent changes of ECG morphology | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| ΔQTcF for moxifloxacin | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| ΔΔQTcF for moxifloxacin | Part B | Up to Day 13 of Period 4 (Each period is 17 days) |
| Number of participants with non-serious AEs | Part B | Until 28 days post last treatment dose |
| Number of participants with SAEs | Part B | Until 28 days post last treatment dose |
| Number of participants with AEs leading to study intervention discontinuation | Part B | Until 28 days post last treatment dose |
| Number of participants with vital sign abnormalities | Part B | Up to Day 18 of Period 4 (Each period is 17 days) |
| Number of participants with clinical laboratory assessment abnormalities | Part B | Up to Day 17 of Period 4 (Each period is 17 days) |
| Number of participants with 12-lead ECG abnormalitie | Part B | Up to Day 17 of Period 4 (Each period is 17 days) |
| Number of participants with physical examination abnormalities | Part B | Up to Day 18 of Period 4 (Each period is 17 days) |
| Salt Lake City |
| Utah |
| 84124 |
| United States |
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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