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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04113668
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
1.8
Actual Duration (Months)
26.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Oct 1, 2019
Actual Primary Completion Date :
Nov 19, 2019
Actual Study Completion Date :
Nov 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Single Dose (BMS-986165)

Drug: BMS-986165
Specified Dose on Specified Days
Experimental: Arm B:Diflunisal and Single Dose (BMS-986165)

Drug: BMS-986165
Specified Dose on Specified Days

Drug: diflunisal
Specified Dose on Specified Days

Outcome Measures

Primary Outcome Measures

  1. Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor [Up to 14 days]

  2. Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor [up to 14 days]

  3. 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 Outcome Measures

  1. Incidence of Adverse Events (AEs) [up to 48 days]

  2. Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities [up to 48 days]

  3. Physical Examination of weight [up to 48 days]

  4. Number of changes in blood pressure [up to 20 days]

  5. Number of changes in body temperature [up to 20 days]

  6. Number of changes in respiratory rate [up to 20 days]

  7. Number of clinical significant changes in lab assessment of blood serum [up to 48 days]

  8. Number of Clinically significant changes in assessment of blood [up to 20 days]

  9. Number of Clinically significant changes in lab assessment of urine [up to 20 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PRA Health Sciences - Lenexa Lenexa Kansas United States 66219

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT04113668
Other Study ID Numbers:
  • IM011-101
First Posted:
Oct 3, 2019
Last Update Posted:
Aug 5, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diflunisal
BMS-986165

Study Results

No Results Posted as of Aug 5, 2020