A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effec… (NCT06746402) | Clinical Trial Compass
CompletedPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants
United States42 participantsStarted 2025-02-10
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Number of participants with non-serious Adverse Events (AEs)
Timeframe: Until 28 days post last treatment dose
2
Number of participants with Serious AEs (SAEs)
Timeframe: Until 28 days post last treatment dose
3
Number of participants with AEs leading to study intervention discontinuation
Timeframe: Until 28 days post last treatment dose
4
Number of participants with vital sign abnormalities
Timeframe: Up to Day 18
5
Number of participants with clinical laboratory assessment abnormalities
Timeframe: Up to Day 18
6
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Timeframe: Up to Day 18
7
Number of participants with physical examination abnormalities
Timeframe: Up to Day 18
8
Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)