Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113668
Recruitment Status : Completed
First Posted : October 3, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Healthy Participants Drug: BMS-986165 Drug: diflunisal Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 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 : September 30, 2019
Actual Primary Completion Date : November 4, 2019
Actual Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Diflunisal

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




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor [ Time Frame: Up to 14 days ]
  2. Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor [ Time Frame: 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 [ Time Frame: up to 14 days ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: up to 48 days ]
  2. Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities [ Time Frame: up to 48 days ]
  3. Physical Examination of weight [ Time Frame: up to 48 days ]
  4. Number of changes in blood pressure [ Time Frame: up to 20 days ]
  5. Number of changes in body temperature [ Time Frame: up to 20 days ]
  6. Number of changes in respiratory rate [ Time Frame: up to 20 days ]
  7. Number of clinical significant changes in lab assessment of blood serum [ Time Frame: up to 48 days ]
  8. Number of Clinically significant changes in assessment of blood [ Time Frame: up to 20 days ]
  9. Number of Clinically significant changes in lab assessment of urine [ Time Frame: up to 20 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113668


Locations
Layout table for location information
United States, Kansas
PRA Health Sciences - Lenexa
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04113668    
Other Study ID Numbers: IM011-101
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diflunisal
BMS-986165
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors