COMPLETED

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants

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Healthy Volunteers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-02-10
Study Completion:2025-09-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06746402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female individuals not of childbearing potential (INOCBP) and males.
  2. * Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
  3. * Body mass index (BMI) 18.0 to 32.0 kg/m2 , inclusive, for Parts A and B.
  1. * Any significant acute or chronic medical illness as determined by the investigator.
  2. * 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.
  3. * 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.
  4. * Other protocol-defined inclusion/exclusion criteria apply.

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

ICON San Antonio
San Antonio, Texas, 78209
United States
Local Institution - 0001
Salt Lake City, Utah, 84124
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-10
Study Completion Date2025-09-11

Study Record Updates

Study Start Date2025-02-10
Study Completion Date2025-09-11

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy Volunteers