Healthy Participants
Conditions
Brief summary
The purpose of this study is to investigate experimental medication BMS-986278 given to healthy participants.
Interventions
DRUGBMS-986278
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants must be in good general health in the opinion of the investigator * Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)2 * Body weight between 55 and 105 kg, inclusive, at screening * Female participants must have documented proof that they are not of childbearing potential * Participants in the Japanese cohorts must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
Exclusion criteria
* Women who are of childbearing potential or breastfeeding * Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome * History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator * Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug * Any major surgery within 6 weeks of study drug administration Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation | Up to 30 days |
| Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations | Up to 30 days |
Countries
Netherlands, United Kingdom
Outcome results
None listed