Clinical trial NCT04113668: The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-10-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor
timeFrame: Up to 14 days
measure: Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor
timeFrame: up to 14 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) for BMS-986165 with and without UGT1A9 inhibitor
timeFrame: up to 14 days
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: up to 48 days
measure: Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
timeFrame: up to 48 days
measure: Physical Examination of weight
timeFrame: up to 48 days
measure: Number of changes in blood pressure
timeFrame: up to 20 days
measure: Number of changes in body temperature
timeFrame: up to 20 days
measure: Number of changes in respiratory rate
timeFrame: up to 20 days
measure: Number of clinical significant changes in lab assessment of blood serum
timeFrame: up to 48 days
measure: Number of Clinically significant changes in assessment of blood
timeFrame: up to 20 days
measure: Number of Clinically significant changes in lab assessment of urine
timeFrame: up to 20 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences - Lenexa
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: