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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986165; Drug: diflunisal

Study type: Interventional

Funder types: Industry

Identifiers

NCT04113668

IM011-101

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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/exclusion criteria apply

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Arm A: Single Dose (BMS-986165)

Experimental group

Treatment:

Drug: BMS-986165

Arm B:Diflunisal and Single Dose (BMS-986165)

Experimental group

Treatment:

Drug: BMS-986165

Drug: diflunisal