The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
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.
Key facts
- Study ID
- NCT04113668
- Run by
- Bristol-Myers Squibb
- People needed
- 48
- Starts
- 2019-10-01
- Expected to finish
- 2019-11-25
- Last updated by the study team
- 2020-08-05
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- PRA Health Sciences - Lenexa — Lenexa, Kansas, United States
Full record on ClinicalTrials.gov
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