BMS-986419 for Drug Interaction in Healthy Subjects

No longer recruiting at 1 trial location

Overseen By First line of the email MUST contain NCT # and Site #.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Chronic illness, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how BMS-986419, an experimental treatment, affects the body's processing of certain common drugs. Researchers seek to determine how BMS-986419 interacts with drugs like caffeine, which many consume daily, and others like bupropion and omeprazole, used for depression and acid reflux, respectively. The trial focuses on healthy individuals without major health issues or a history of significant medical problems. Participants should have a body mass index (BMI) between 18 and 32 and weigh at least 50 kg. As a Phase 1 trial, this research explores how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves assessing the effect of a new drug on other substances, it's possible that some medications might need to be paused. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that BMS-986419 is likely to be safe for humans?

Research shows that BMS-986419 is under study for its safety and effects. Although specific safety data for BMS-986419 is not yet available, similar drugs have shown promising results. For example, a related drug, BMS-986001, was generally safe in studies. This suggests that BMS-986419 might also be well-tolerated. However, since this trial is in an early stage, the main goal is to learn about its safety and side effects in people. Participants should understand that while early trials provide important safety information, they also involve some uncertainty. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BMS-986419 because it could offer a novel approach to drug interaction management. Unlike current treatments that may not account for complex drug interactions, BMS-986419 is designed to evaluate how it affects the levels of various drugs in the body when administered together with probe substrates. This unique focus can lead to better understanding and possibly safer medication regimens, as it aims to provide insights into how medications interact at a metabolic level. This innovation could significantly enhance patient safety and treatment efficacy by tailoring medication plans to minimize adverse interactions.

What evidence suggests that BMS-986419 could be effective in affecting the pharmacokinetics of these substrates?

The trial studies BMS-986419, a new drug, to understand its effects on how the body processes other medications. Participants will receive a combination of cocktail probe substrates and BMS-986419. Research has shown that BMS-986419 might alter the blood levels of certain drugs, such as caffeine, bupropion (used for depression), and omeprazole (for stomach issues). The goal is to learn how BMS-986419 interacts with these drugs. Although still in early stages, the hope is that this information will help doctors manage medication use more effectively with BMS-986419. ^{1 5 6 7 8}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

Inclusion Criteria

Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded.

Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -1)

Exclusion Criteria

Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator

Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention

Other protocol-defined inclusion/exclusion criteria apply.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single doses of probe substrates and BMS-986419 to assess pharmacokinetics

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986419

How Is the Trial Designed?

Group I: Cocktail Probe Substrates + BMS-986419 Experimental Treatment 7 Interventions

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

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05932277

A Study to Assess the Effect of BMS-986419 on the Single ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. bmsstudyconnect.com bmsstudyconnect.com/es/en/clinical-trials/NCT05932277.html

A Study to Assess the Effect of BMS-986419 on the Single ... The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), ...

3. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT05932277

Trial ID CN007-1000 | NCT05932277 - BMS Clinical Trials The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/BMY/pressreleases/35738283/bristol-myers-squibbs-new-study-on-bms-986419-a-potential-game-changer-in-cardiac-health/

Bristol-Myers Squibb's New Study on BMS-986419 The primary purpose is treatment-focused, ensuring unbiased results in evaluating BMS-986419's effects. Study Timeline: The study began on ...

5. bmsstudyconnect.com bmsstudyconnect.com/dk/en/clinical-trials/NCT05963932.html

study connect - BMS Clinical Trials The purpose of this study is to assess the impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current ...

6. adisinsight.springer.com adisinsight.springer.com/drugs/800065380

BMS 986419 - AdisInsight - Springer BMS 986419, also known as eIF2b activator, is an antidementia drug developed by Bristol-Myers Squibb, with a mechanism of action as Eukaryotic initiation ...

7. synapse.patsnap.com synapse.patsnap.com/drug/185df9ea12a1466fb41dc3d2cced9e26

BMS-986419 - Drug Targets, Indications, Patents A Phase 1, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986419 (Part 1) and a Phase 1 ...

8. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-1-2025-1bbfb

BMS-986419 for Healthy Subjects There is no specific safety data available for BMS-986419, but similar compounds like BMS-986001 and BMS-378806 have been studied. BMS-986001 was generally safe ...