Healthy Volunteers
Conditions
Brief summary
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.
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)
Masking description
This is a double-blind study, with an open-label positive control in Part B.
Intervention model description
Part A, a parallel model, will be followed by Part B, a 4-way crossover model.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Female individuals not of childbearing potential (INOCBP) and males. * Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments. * Body mass index (BMI) 18.0 to 32.0 kg/m2 , inclusive, for Parts A and B.
Exclusion criteria
* Any significant acute or chronic medical illness as determined by the investigator. * History of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for ventricular arrhythmias. * Any significant history of disease of the cardiovascular system that in the opinion of the Investigator makes the participant unsuitable for enrollment into the study. * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Placebo-corrected change from baseline QTcF (ΔΔQTcF) | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Number of participants with non-serious Adverse Events (AEs) | Until 28 days post last treatment dose | Part A |
| Number of participants with Serious AEs (SAEs) | Until 28 days post last treatment dose | Part A |
| Number of participants with AEs leading to study intervention discontinuation | Until 28 days post last treatment dose | Part A |
| Number of participants with vital sign abnormalities | Up to Day 18 | Part A |
| Number of participants with clinical laboratory assessment abnormalities | Up to Day 18 | Part A |
| Number of participants with 12-lead electrocardiogram (ECG) abnormalities | Up to Day 18 | Part A |
| Number of participants with physical examination abnormalities | Up to Day 18 | Part A |
| Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF) | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Placebo-corrected change from baseline HR (ΔΔHR) | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Placebo-corrected change from baseline QRS interval (ΔΔQRS) | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Number of participants with categorical outliers for QTcF | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Number of participants with categorical outliers for HR | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Number of participants with categorical outliers for PR interval | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Number of participants with categorical outliers for QRS interval | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Number of participants with treatment-emergent changes of ECG morphology | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| ΔQTcF for moxifloxacin | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Placebo-corrected Change from baseline PR interval (ΔΔPR) | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Number of participants with non-serious AEs | Until 28 days post last treatment dose | Part B |
| Number of participants with SAEs | Until 28 days post last treatment dose | Part B |
| Number of participants with AEs leading to study intervention discontinuation | Until 28 days post last treatment dose | Part B |
| Number of participants with vital sign abnormalities | Up to Day 18 of Period 4 (Each period is 17 days) | Part B |
| Number of participants with clinical laboratory assessment abnormalities | Up to Day 17 of Period 4 (Each period is 17 days) | Part B |
| Number of participants with 12-lead ECG abnormalitie | Up to Day 17 of Period 4 (Each period is 17 days) | Part B |
| Number of participants with physical examination abnormalities | Up to Day 18 of Period 4 (Each period is 17 days) | Part B |
| ΔΔQTcF for moxifloxacin | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Maximum observed plasma concentration (Cmax) | Up to Day 13 of Period 4 (Each period is 17 days) | Part A and Part B |
| Time of maximum observed plasma concentration (Tmax) | Up to Day 13 of Period 4 (Each period is 17 days) | Part A and Part B |
| Area under the plasma concentration-time curve from time zero to the end of dosing interval AUC(TAU) | Up to Day 13 of Period 4 (Each period is 17 days) | Part A and Part B |
| Terminal half-life (T-HALF) | Up to Day 18 | Part A |
| Apparent total body clearance (CLT/F) | Up to Day 18 | Part A |
| Change from baseline heart rate (HR) (∆HR) | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Change from baseline PR interval (∆PR) | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
| Change from baseline QRS interval (∆QRS) | Up to Day 13 of Period 4 (Each period is 17 days) | Part B |
Countries
United States
Outcome results
None listed