A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants
Phase 1
Recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT06746402
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
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/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part B3 Treatment D Placebo - Part B3 Treatment D Moxifloxacin - Part A Placebo - Part B1/B2 Treatment B Placebo - Part B1/B2 Treatment C Placebo - Part B1/B2 Treatment D Placebo - Part B1/B2 Treatment D Moxifloxacin - Part B3 Treatment B Placebo - Part B3 Treatment C Placebo - Part A BMS-986278 - Part B1/B2 Treatment A BMS-986278 - Part B1/B2 Treatment B BMS-986278 - Part B3 Treatment A BMS-986278 - Part B3 Treatment B BMS-986278 -
- Primary Outcome Measures
Name Time Method 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
Placebo-corrected change from baseline QTcF (ΔΔQTcF) Up to Day 13 of Period 4 (Each period is 17 days) Part B
- Secondary Outcome Measures
Name Time Method 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
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 PR interval (ΔΔPR) 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
ΔΔQTcF for moxifloxacin 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular targets of BMS-986278 in cardiac repolarization modulation?
How does BMS-986278 compare to moxifloxacin in QTc prolongation risk assessment?
Which biomarkers predict cardiac repolarization effects of BMS-986278 in healthy subjects?
What are the potential adverse events associated with BMS-986278 in Phase 1 trials?
Are there other Bristol-Myers Squibb compounds with similar cardiac safety profiles to BMS-986278?
Trial Locations
- Locations (2)
ICON Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Local Institution - 0002
🇺🇸San Antonio, Texas, United States