Mediators of Inflammation
Conditions
Brief summary
This is a study of experimental medication BMS-986235 in healthy subjects.
Interventions
DRUGBMS-986235
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
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations * Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive
Exclusion criteria
* Patients that are pregnant * Patient with any significant acute or chronic medical illness * Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption * Patient with any surgery within 12 weeks of study treatment administration * Patient with any gastrointestinal surgery that could impact upon the absorption of study drug * Patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only) * Patient who received a blood transfusion within 12 weeks of study drug administration Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of serious adverse events (SAE) | Approximately 30 days |
| Number of deaths | Approximately 30 days |
| Number of adverse events (AE) leading to study discontinuation | Approximately 30 days |
| Number of patients with clinically significant changes in ECG parameters, as defined by the investigator | Approximately 30 days |
| Number of patients with potentially clinically significant changes in vital signs | Approximately 30 days |
Countries
United States
Outcome results
None listed