The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants
NCT ID: NCT04113668
Last Updated: 2020-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2019-10-01
2019-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Arm A: Single Dose (BMS-986165)
BMS-986165
Specified Dose on Specified Days
Arm B:Diflunisal and Single Dose (BMS-986165)
BMS-986165
Specified Dose on Specified Days
diflunisal
Specified Dose on Specified Days
Interventions
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BMS-986165
Specified Dose on Specified Days
diflunisal
Specified Dose on Specified Days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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PRA Health Sciences - Lenexa
Lenexa, Kansas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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IM011-101
Identifier Type: -
Identifier Source: org_study_id
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