71 Participants Needed

Drug Interaction Study in Healthy Subjects

Recruiting at 2 trial locations
BS
Fl
BC
Overseen ByBMS Clinical Trials Contact Center www.BMSClinicaltrials.com
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

BMS-986278 is a promising drug because it is being studied for its potential to interact beneficially with other medications, which can enhance its effectiveness or reduce costs. This makes it a valuable option in treating certain conditions.49101112

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

BS

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

My BMI is between 18.0 and 32.0.
I am a healthy male or female.
My body weight is 50 kg or more.

Exclusion Criteria

My health tests show no major organ problems or significant abnormalities.
Other protocol-defined Inclusion/Exclusion criteria apply
I have previously been treated with BMS-986278 or participated in a drug trial within the last 4 weeks.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part I: Period A

Initial assessment of pharmacokinetic interaction between BMS-986278 and Nintedanib

2 weeks

Part I: Period B

Continuation of pharmacokinetic studies with different conditions

2 weeks

Part I: Period C

Further pharmacokinetic evaluation under varied conditions

2 weeks

Part II: Period 1

Assessment of relative bioavailability of BMS-986278 tablet formulations

2 weeks

Part II: Period 2

Further evaluation of bioavailability with different formulations

2 weeks

Part II: Period 3

Final assessment of bioavailability and food effect on BMS-986278

2 weeks

Part III: Period 1

Evaluation of food effect on pharmacokinetics of BMS-986278

2 weeks

Part III: Period 2

Completion of food effect studies on BMS-986278

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • BMS-986278
Trial Overview The study is testing the interaction between two drugs: Nintedanib and BMS-986278, as well as how food influences the uptake of BMS-986278 from tablets into the body.
Participant Groups
8Treatment groups
Experimental Treatment
Group I: Part III: Period 2Experimental Treatment1 Intervention
Group II: Part III: Period 1Experimental Treatment1 Intervention
Group III: Part II: Period 3Experimental Treatment1 Intervention
Group IV: Part II: Period 2Experimental Treatment1 Intervention
Group V: Part II: Period 1Experimental Treatment1 Intervention
Group VI: Part I: Period CExperimental Treatment2 Interventions
Group VII: Part I: Period BExperimental Treatment1 Intervention
Group VIII: Part I: Period AExperimental Treatment1 Intervention

BMS-986278 is already approved in United States for the following indications:

🇺🇸
Approved in United States as BMS-986278 for:
  • Progressive Pulmonary Fibrosis (Breakthrough Therapy Designation)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

A study analyzing drug labels found that 73% of clinically relevant drug-drug interactions (DDIs) related to CYP2C19, CYP2D6, and CYP2C9 also included corresponding gene-drug interactions (GDIs), indicating a strong link between genetic factors and drug metabolism.
Among the drug labels reviewed, 43% provided specific management recommendations for DDIs, while 17% did so for GDIs, showing that the FDA acknowledges the need for dose adjustments or alternative medications based on genetic differences in drug metabolism.
Consistency of drug-drug and gene-drug interaction information in US FDA-approved drug labels.Conrado, DJ., Rogers, HL., Zineh, I., et al.[2016]
In a study involving 484 neurological inpatients and 2812 prescriptions, the clinical decision support software (CDSS) MediQ generated more alerts (1759) than ID PHARMA CHECK (1082), but both systems identified a total of 808 unique potentially interacting drug combinations.
The positive predictive value for clinically relevant alerts was low for both systems, with MediQ at 0.24 and ID PHARMA CHECK at 0.48, indicating that many alerts may not represent significant clinical risks, highlighting the need for improved alert management in CDSS development.
Comparative evaluation of the drug interaction screening programs MediQ and ID PHARMA CHECK in neurological inpatients.Zorina, OI., Haueis, P., Semmler, A., et al.[2012]
In a phase 1 study involving 28 patients with advanced cancer, tivantinib at a dose of 360 mg twice daily showed minimal to no effect on the pharmacokinetics of several CYP enzyme substrates, indicating it is unlikely to interfere significantly with these drugs.
However, tivantinib did reduce the systemic exposure of P-glycoprotein substrates, such as digoxin, suggesting that caution may be needed when co-administering these medications.
Evaluation of the pharmacokinetic drug interaction potential of tivantinib (ARQ 197) using cocktail probes in patients with advanced solid tumours.Tachibana, M., Papadopoulos, KP., Strickler, JH., et al.[2021]

References

Consistency of drug-drug and gene-drug interaction information in US FDA-approved drug labels. [2016]
Comparative evaluation of the drug interaction screening programs MediQ and ID PHARMA CHECK in neurological inpatients. [2012]
Evaluation of the pharmacokinetic drug interaction potential of tivantinib (ARQ 197) using cocktail probes in patients with advanced solid tumours. [2021]
Drug interaction studies during drug development: which, when, how? [2005]
Potential cytochrome P-450 drug-drug interactions in adults with metastatic solid tumors and effect on eligibility for Phase I clinical trials. [2019]
Prevalence and Accuracy of Information on CYP2D6, CYP2C19, and CYP2C9 Related Substrate and Inhibitor Co-Prescriptions in the General Population: A Cross-Sectional Descriptive Study as Part of the PharmLines Initiative. [2023]
The regulatory view on drug-drug interactions. [2013]
Importance of cytochrome P450 (CYP450) in adverse drug reactions due to drug-drug interactions: a PharmacoVigilance study in France. [2021]
A basic conceptual and practical overview of interactions with highly prescribed drugs. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Drug interactions with itraconazole, fluconazole, and terbinafine and their management. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Effect of Cilostazol on the Pharmacokinetics of Simvastatin in Healthy Subjects. [2022]
Pharmacokinetic-pharmacodynamic consequences and clinical relevance of cytochrome P450 3A4 inhibition. [2022]
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