A Study to Evaluate the Effect of BMS-986278 on Cardiac Repolarization in Healthy Participants
A Phase 1, 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 in Healthy Participants
1 other identifier
interventional
32
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of BMS-986278 on the cardiac repolarization in healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2026
CompletedStudy Start
First participant enrolled
February 19, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2026
March 17, 2026
March 1, 2026
4 months
February 12, 2026
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (23)
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
- +18 more secondary outcomes
Study Arms (4)
Treatment A
EXPERIMENTALTreatment B
EXPERIMENTALTreatment C
PLACEBO COMPARATORTreatment D
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Worldwide Clinical Trials
San Antonio, Texas, 78217, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2026
First Posted
February 20, 2026
Study Start
February 19, 2026
Primary Completion (Estimated)
June 15, 2026
Study Completion (Estimated)
June 15, 2026
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html