The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants
- Registration Number
- NCT04113668
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm A: Single Dose (BMS-986165) BMS-986165 - Arm B:Diflunisal and Single Dose (BMS-986165) BMS-986165 - Arm B:Diflunisal and Single Dose (BMS-986165) diflunisal -
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method Number of changes in body temperature up to 20 days Number of changes in respiratory rate up to 20 days Number of Clinically significant changes in assessment of blood up to 20 days Number of clinical significant changes in lab assessment of blood serum up to 48 days Number of Clinically significant changes in lab assessment of urine up to 20 days Incidence of Adverse Events (AEs) up to 48 days Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities up to 48 days Physical Examination of weight up to 48 days Number of changes in blood pressure up to 20 days
Trial Locations
- Locations (1)
PRA Health Sciences - Lenexa
🇺🇸Lenexa, Kansas, United States