Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate the effect of BMS-986278 on the cardiac repolarization in healthy participants.
Interventions
DRUGBMS-986278
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
DRUGMoxifloxacin
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Female individuals not of childbearing potential and males. * Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments. * 18 to 55 years of age, inclusive, at the time of signing the informed consent with a BMI 18.0 to 32.0 kg/m2, inclusive. * Other protocol-defined Inclusion/
Exclusion criteria
apply.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 | 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 |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed