BMS-986278 for Healthy Subjects

No longer recruiting at 3 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Cardiac disease, Arrhythmias, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a medication called BMS-986278, an experimental treatment, to assess its safety and interaction with the body and heart rhythms in healthy individuals. The study involves different groups receiving various treatments to gather comprehensive data. It seeks healthy participants, specifically women who cannot have children and men, with a body mass index (BMI) between 18.0 and 32.0. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that you may need to pause certain medications. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In studies on BMS-986278, researchers have assessed its safety across different groups. One study with healthy participants found that the treatment was generally well-tolerated, with no serious side effects. Most side effects, such as headaches or mild stomach discomfort, were mild and temporary.

Another study focused on individuals with lung conditions and found similar results, with participants mostly experiencing mild side effects. This suggests the treatment might be safe for humans based on the data collected so far.

However, this current trial is in an early phase, and researchers are still learning about its safety in healthy people. While early findings are promising, more data is needed to fully understand the safety of BMS-986278. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BMS-986278 because it targets a unique mechanism that current treatments for similar conditions might not address. While most treatments work by alleviating symptoms, BMS-986278 acts on a different pathway, potentially offering a more targeted and effective approach. Additionally, its new active ingredient could provide benefits where existing therapies fall short, such as faster onset of action or fewer side effects. This distinctive approach holds promise for improving outcomes and enhancing quality of life for patients.

What evidence suggests that this trial's treatments could be effective?

Research has shown that BMS-986278 may help treat lung fibrosis. One study demonstrated that taking a 60 mg dose twice a day reduced the rate of lung function decline by 69% over 26 weeks. This indicates that the treatment can significantly slow lung damage. Reports also indicate that it is safe and well tolerated. These results are promising for further research in ongoing studies, including the current trial, which will explore various treatment arms with BMS-986278. ^{1 3 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?

This trial is for healthy individuals who can safely receive high doses of a new drug, BMS-986278. Participants should not have any known health conditions that could interfere with the study or pose additional risks.

Inclusion Criteria

I am either a male or a female not able to have children.

I am healthy based on recent medical exams and tests.

Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive, for Parts A and B

Exclusion Criteria

My heart health does not prevent me from joining this study.

Other protocol-defined inclusion/exclusion criteria apply

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive high dose of BMS-986278 to assess safety, tolerability, and pharmacokinetics

Up to 18 days

Treatment Part B

Participants undergo a 4-period crossover study to evaluate the effect of BMS-986278 on cardiac repolarization

Up to 68 days (4 periods of 17 days each)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days post last treatment dose

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986278

Trial Overview The study tests the safety and tolerability of BMS-986278 in healthy people. It also looks at how the body processes the drug (pharmacokinetics) and its effects on heart electrical activity as measured by ECG intervals.

How Is the Trial Designed?

Group I: Part B3 Treatment D Experimental Treatment 2 Interventions

Group II: Part B3 Treatment C Experimental Treatment 1 Intervention

Group III: Part B3 Treatment B Experimental Treatment 2 Interventions

Group IV: Part B3 Treatment A Experimental Treatment 1 Intervention

Group V: Part B1/B2 Treatment D Experimental Treatment 2 Interventions

Group VI: Part B1/B2 Treatment C Experimental Treatment 1 Intervention

Group VII: Part B1/B2 Treatment B Experimental Treatment 2 Interventions

Group VIII: Part B1/B2 Treatment A Experimental Treatment 1 Intervention

Group IX: Part A Experimental Treatment 2 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/NCT04308681

NCT04308681 | A Study Measuring the Effectiveness, ... The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis.

2. news.bms.com news.bms.com/news/details/2023/Bristol-Myers-Squibbs-Investigational-LPA1-Antagonist-Reduces-Rate-of-Lung-Function-Decline-in-Progressive-Pulmonary-Fibrosis-Cohort-of-Phase-2-Study/default.aspx

Bristol Myers Squibb's Investigational LPA1 Antagonist ... Results show 26 weeks of treatment with twice-daily 60 mg dose of BMS-986278 resulted in a 69% relative reduction in the rate of decline in ...

3. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.202405-0977OC

Efficacy and Safety of Admilparant, an LPA 1 Antagonist ... 60-mg admilparant slowed lung function decline and was safe and well tolerated, supporting further evaluation in phase 3 trials.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8718498/

Phase 2 trial design of BMS-986278, a lysophosphatidic acid ... Results from in vitro studies show that, unlike BMS-986020, BMS-986278 does not inhibit liver efflux transporters, particularly bile salt export ...

5. clinicaltrials.eu clinicaltrials.eu/inn/bms-986278/

Bms-986278 – Application in Therapy and Current ... The trials are measuring various outcomes, including changes in lung function, quality of life, and disease progression. Early-phase studies in healthy ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39393084/

Efficacy and Safety of Admilparant, an LPA1 Antagonist, in ... Objectives: Assess efficacy and safety of admilparant (BMS-986278), an oral lysophosphatidic acid receptor 1 antagonist, in patients with IPF and PPF.

7. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/safetypk-pd-and-food-effect-of-bms-986278-given-in-sad-and-mad-in-hv/

Safety,PK, PD and food effect of BMS-986278 given in SAD ... Up to 24 healthy Japanese male or female subjects, aged 21-65 years will be included. There will be three consecutive groups (cohorts) of up to eight subjects ( ...

8. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2019-003992-21/IT

Clinical Trials Register A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in ...