The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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AN OPEN-LABEL, SINGLE-SEQUENCE, CROSSOVER STUDY TO INVESTIGATE THE EFFECTS OF UGT1A9 INHIBITOR DIFLUNISAL, AT STEADY-STATE, ON PHARMACOKINETICS OF A SINGLE DOSE OF BMS-986165 IN HEALTHY MALE AND FEMALE VOLUNTEERS

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986165
* Drug: diflunisal


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Single Dose (BMS-986165)<br> | Drug: BMS-986165<br>* Specified Dose on Specified Days<br>|
| Experimental: Arm B:Diflunisal and Single Dose (BMS-986165)<br> | Drug: BMS-986165<br>* Specified Dose on Specified Days<br>Drug: diflunisal<br>* Specified Dose on Specified Days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of changes in body temperature |  | up to 20 days | 
| Number of changes in respiratory rate |  | 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 assessment of blood |  | up to 20 days | 
| Number of Clinically significant changes in lab assessment of urine |  | up to 20 days |