Drug Interaction Study in Healthy Subjects
Trial Summary
Do I have to stop taking my current medications for this trial?
The protocol does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants and involves drug interaction studies, it's possible that you may need to pause some medications. Please consult with the trial coordinators for specific guidance.
What data supports the idea that Drug Interaction Study in Healthy Subjects is an effective drug?
The available research does not provide specific data supporting the effectiveness of Drug Interaction Study in Healthy Subjects (BMS-986278) as a treatment. The articles focus on drug interactions and the evaluation of drug interaction programs, rather than the effectiveness of BMS-986278 itself. Therefore, there is no direct evidence from the provided information to support its effectiveness as a treatment.12345
What safety data is available for BMS-986278?
The provided research does not contain specific safety data for BMS-986278, BMS986278, or compound 33. The studies focus on drug-drug interactions, particularly involving cytochrome P450 enzymes, but do not mention this specific compound. Therefore, no direct safety data for BMS-986278 is available in the given research.678910
Is BMS-986278 a promising drug?
What is the purpose of this trial?
The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants
Research Team
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
This trial is for healthy men and women with a BMI between 18.0 to 32.0 kg/m2, and weighing at least 50 kg. It's designed to understand how BMS-986278 interacts with another drug (Nintedanib) in the body and how food affects its absorption when taken in tablet form.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Part I: Period A
Initial assessment of pharmacokinetic interaction between BMS-986278 and Nintedanib
Part I: Period B
Continuation of pharmacokinetic studies with different conditions
Part I: Period C
Further pharmacokinetic evaluation under varied conditions
Part II: Period 1
Assessment of relative bioavailability of BMS-986278 tablet formulations
Part II: Period 2
Further evaluation of bioavailability with different formulations
Part II: Period 3
Final assessment of bioavailability and food effect on BMS-986278
Part III: Period 1
Evaluation of food effect on pharmacokinetics of BMS-986278
Part III: Period 2
Completion of food effect studies on BMS-986278
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BMS-986278
BMS-986278 is already approved in United States for the following indications:
- Progressive Pulmonary Fibrosis (Breakthrough Therapy Designation)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania