Healthy Participants
Conditions
Brief summary
BMS-986165 Is broken down by the body through multiple pathways. This study Investigates the effect of blocking one pathway in the drug levels of BMS-986165 in health subjects.
Interventions
DRUGBMS-986165
Specified Dose on Specified Days
DRUGdiflunisal
Specified Dose on Specified Days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Women and men must agree to follow instructions for methods of contraception. * Participants must be willing and able to complete all study-specific procedures and visits. * A healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. * WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.
Exclusion criteria
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of active liver disease * History of biliary disorders, including Gilbert's syndrome or Dubin- Johnson disease, in addition to, current or recent gastrointestinal disease that could impact the absorption of study drug. * Participants using electronic cigarettes or nicotine-containing products who have stopped smoking less than 6 months prior to dosing on Day 1. * Consumption of chargrilled meat, quinine, or any nutrient known to modulate CYP enzyme activity within 14 days prior to first administration of study treatment. * History of any significant drug allergy Other inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor | Up to 14 days |
| Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor | up to 14 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) for BMS-986165 with and without UGT1A9 inhibitor | up to 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Physical Examination of weight | up to 48 days |
| Number of changes in blood pressure | up to 20 days |
| Number of changes in respiratory rate | up to 20 days |
| Number of changes in body temperature | up to 20 days |
| Number of Clinically significant changes in assessment of blood | up to 20 days |
| Number of Clinically significant changes in lab assessment of urine | up to 20 days |
| Number of clinical significant changes in lab assessment of blood serum | up to 48 days |
| Incidence of Adverse Events (AEs) | up to 48 days |
| Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities | up to 48 days |
Countries
United States
Outcome results
None listed