Back to resultsA Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants
Primary Purpose
Healthy Participants
Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
BMS-986278
Itraconazole
Gemfibrozil
Carbamazepine
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Participants focused on measuring BMS-986278, Itraconazole, Gemfibrozil, Carbamazepine, Idiopathic pulmonary fibrosis, Drug interaction
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) through 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])2. Body weight ≥ 50 kg for males and ≥ 45 kg for females. Exclusion Criteria: Any significant acute or chronic medical illness. Any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed. Any major surgery within 4 weeks of study intervention administration. Other protocol-defined inclusion/exclusion criteria apply.
Sites / Locations
- Local Institution - 0001Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
BMS-986278, followed by itraconazole
BMS-986278, followed by gemfibrozil
BMS-986278, followed by carbamazepine
Arm Description
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax)
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Secondary Outcome Measures
Number of participants with adverse events (AEs)
Number of participants with physical examination abnormalities
Number of participants with vital sign abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with clinical laboratory abnormalities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05932303
Brief Title
A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants
Official Title
A Phase 1, 3-arm, Open-label, Sequential Design Study to Investigate the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on Single-dose Pharmacokinetics of BMS-986278 in Healthy Participants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2023 (Actual)
Primary Completion Date
October 3, 2023 (Anticipated)
Study Completion Date
October 3, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study in healthy participants designed to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of BMS-986278.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants
Keywords
BMS-986278, Itraconazole, Gemfibrozil, Carbamazepine, Idiopathic pulmonary fibrosis, Drug interaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BMS-986278, followed by itraconazole
Arm Type
Experimental
Arm Title
BMS-986278, followed by gemfibrozil
Arm Type
Experimental
Arm Title
BMS-986278, followed by carbamazepine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986278
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Itraconazole
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Gemfibrozil
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Carbamazepine
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to 33 days
Title
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Time Frame
Up to 33 days
Title
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time Frame
Up to 33 days
Secondary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 33 days
Title
Number of participants with physical examination abnormalities
Time Frame
Up to 33 days
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 33 days
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
Up to 33 days
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 33 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) through 32.0 kg/m^2, inclusive.
BMI = weight (kg)/(height [m])2.
Body weight ≥ 50 kg for males and ≥ 45 kg for females.
Exclusion Criteria:
Any significant acute or chronic medical illness.
Any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed.
Any major surgery within 4 weeks of study intervention administration.
Other protocol-defined inclusion/exclusion criteria apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0001
City
Québec
State/Province
CA
ZIP/Postal Code
G1P 0A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/ disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants
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