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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113668
• Other study ID #: IM011-101
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2019
• Est. completion date: November 25, 2019

Study information

• Verified date: August 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 25, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986165
Specified Dose on Specified Days
• diflunisal
Specified Dose on Specified Days

Locations

Country	Name	City	State
United States	PRA Health Sciences - Lenexa	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor		Up to 14 days
Primary	Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor		up to 14 days
Primary	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	Incidence of Adverse Events (AEs)		up to 48 days
Secondary	Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities		up to 48 days
Secondary	Physical Examination of weight		up to 48 days
Secondary	Number of changes in blood pressure		up to 20 days
Secondary	Number of changes in body temperature		up to 20 days
Secondary	Number of changes in respiratory rate		up to 20 days
Secondary	Number of clinical significant changes in lab assessment of blood serum		up to 48 days
Secondary	Number of Clinically significant changes in assessment of blood		up to 20 days
Secondary	Number of Clinically significant changes in lab assessment of urine		up to 20 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form