Clinical trial NCT06746402: A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants
Official title: A Phase 1, Two-Part, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986278 (Part A) and a Randomized, Double-blind, Positive-controlled, Placebo-controlled, 4-Period Crossover, Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986278 on Cardiac Repolarization (Part B) in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Part A, a parallel model, will be followed by Part B, a 4-way crossover model.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with non-serious Adverse Events (AEs)
timeFrame: Until 28 days post last treatment dose
measure: Number of participants with Serious AEs (SAEs)
timeFrame: Until 28 days post last treatment dose
measure: Number of participants with AEs leading to study intervention discontinuation
timeFrame: Until 28 days post last treatment dose
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 18
measure: Number of participants with clinical laboratory assessment abnormalities
timeFrame: Up to Day 18
measure: Number of participants with 12-lead electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 18
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 18
measure: Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Placebo-corrected change from baseline QTcF (ΔΔQTcF)
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Area under the plasma concentration-time curve from time zero to the end of dosing interval AUC(TAU)
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Terminal half-life (T-HALF)
timeFrame: Up to Day 18
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to Day 18
measure: Change from baseline heart rate (HR) (∆HR)
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Change from baseline PR interval (∆PR)
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Change from baseline QRS interval (∆QRS)
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Placebo-corrected change from baseline HR (ΔΔHR)
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Placebo-corrected Change from baseline PR interval (ΔΔPR)
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Placebo-corrected change from baseline QRS interval (ΔΔQRS)
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Number of participants with categorical outliers for QTcF
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Number of participants with categorical outliers for HR
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Number of participants with categorical outliers for PR interval
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Number of participants with categorical outliers for QRS interval
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Number of participants with treatment-emergent changes of ECG morphology
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: ΔQTcF for moxifloxacin
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: ΔΔQTcF for moxifloxacin
timeFrame: Up to Day 13 of Period 4 (Each period is 17 days)
measure: Number of participants with non-serious AEs
timeFrame: Until 28 days post last treatment dose
measure: Number of participants with SAEs
timeFrame: Until 28 days post last treatment dose
measure: Number of participants with AEs leading to study intervention discontinuation
timeFrame: Until 28 days post last treatment dose
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 18 of Period 4 (Each period is 17 days)
measure: Number of participants with clinical laboratory assessment abnormalities
timeFrame: Up to Day 17 of Period 4 (Each period is 17 days)
measure: Number of participants with 12-lead ECG abnormalitie
timeFrame: Up to Day 17 of Period 4 (Each period is 17 days)
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 18 of Period 4 (Each period is 17 days)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: ICON Salt Lake City
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: