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BMS-986278 for Healthy Subjects

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Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how BMS-986278 affects the heart's electrical activity in healthy individuals. Participants will be divided into four groups: three will receive the experimental treatment, and one will receive a placebo (a treatment with no active ingredient). The trial seeks healthy men and women who cannot have children and can confirm no health issues from their medical history and check-ups. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

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

Research has shown that BMS-986278 has been tested primarily for lung conditions. In these studies, patients generally tolerated the treatment well. Some mild side effects occurred, but they were neither serious nor common. The treatment has been used in various situations and has demonstrated safety. Although this study is in the early stages and focuses on healthy participants, past experience with BMS-986278 suggests it is safe for people.12345

Why are researchers excited about this trial's treatments?

BMS-986278 is unique because it targets specific pathways in the body that are not addressed by current treatments. Most treatments for related conditions focus on broad-spectrum approaches, but BMS-986278 aims to precisely modulate biological processes with potentially fewer side effects. Researchers are excited about its potential to offer a more targeted and effective treatment option with quicker onset of action. This could mean better outcomes for patients and a new direction in therapy development.

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

Research has shown that BMS-986278 may help treat certain lung conditions. In studies with patients who have idiopathic pulmonary fibrosis, a lung disease that causes scarring, BMS-986278 significantly slowed the worsening of lung function. Specifically, the treatment reduced the rate of lung function decline by 69% compared to those not receiving it. This suggests that BMS-986278 could help maintain lung function over time. Although more research is needed, these early results are promising. Participants in this trial will receive different versions of BMS-986278 or a placebo to further evaluate its effects.12678

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for healthy men and women (not able to have children), ages 18-55, with a BMI between 18.0 and 32.0, who pass medical exams including heart tests and lab work.

Inclusion Criteria

I am male or a female who cannot become pregnant.
* Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
I am between 18 and 55 years old and my BMI is between 18.0 and 32.0.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of BMS-986278 or placebo to evaluate its effect on cardiac repolarization

4 periods

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BMS-986278

Trial Overview

The study compares the effects of BMS-986278, placebo, and moxifloxacin on heart rhythm in healthy people. Participants are randomly assigned to receive one of these treatments.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment DExperimental Treatment2 Interventions
Group II: Treatment BExperimental Treatment2 Interventions
Group III: Treatment AExperimental Treatment1 Intervention
Group IV: Treatment CPlacebo Group1 Intervention

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

Citations

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 ...

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 ...

NCT06003426 | A Study to Evaluate the Efficacy, Safety ...

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.

BMS Reports Positive Phase 2 Results in IPF

Bristol Myers Squibb reported positive results from a phase 2 study of its experimental therapy BMS-986278 in patients with idiopathic pulmonary ...

Effect of Admilparant, a Lysophosphatidic Acid Receptor 1 ...

A study to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with idiopathic pulmonary fibrosis. ClinicalTrials.gov identifier ...

A Study Measuring the Effectiveness, Safety, and Tolerability ...

The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the ...

A Study Measuring the Effectiveness, Safety, and Tolerability ...

The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, ...

8.

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.