BMS-986278 Bioavailability Study in Healthy Subjects

No longer recruiting at 1 trial location

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Chronic illness, Recent GI disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 periods

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how well a new formulation of BMS-986278, an experimental treatment, is absorbed by the body compared to an older version. As a Phase 1 trial, it primarily focuses on safety and how the body processes the drug. The trial seeks healthy men and women who are not of childbearing potential, with a body mass index (BMI) between 18 and 32 and a certain minimum weight. Participants should not have significant medical conditions or recent surgeries that might affect medication absorption. As part of this Phase 1 trial, participants will be among the first to receive this new treatment, contributing to essential research on its safety and absorption.

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 trial is for healthy participants, it's likely that you should not be on any significant medications.

Is there any evidence suggesting that BMS-986278 is likely to be safe for humans?

Research has shown that BMS-986278, the drug tested in this trial, has some safety data from earlier studies. Some patients experienced temporary drops in blood pressure after taking it, but these drops were mostly symptomless and didn't cause major problems. This treatment works by blocking certain signals in the body.

Since this trial is in an early phase, researchers are closely monitoring its safety. So far, trials have not reported serious side effects, which is a positive sign. However, because this is an early-phase trial, it's important to understand that not everything about its safety is known yet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for various conditions work by targeting specific pathways or symptoms. But BMS-986278 is unique because it may offer a novel approach by focusing on bioavailability, which means it could be absorbed and utilized by the body more effectively than current options. Researchers are excited about BMS-986278 because this enhanced bioavailability might lead to more consistent therapeutic effects and potentially fewer side effects. This could represent a significant advancement over existing treatments, providing patients with a more reliable and safer option.

What evidence suggests that BMS-986278 could be effective?

Research has shown that BMS-986278 may help treat lung fibrosis. Studies found that taking 60 mg of BMS-986278 twice daily for 26 weeks slowed the decline in lung function. Specifically, it reduced the drop in forced vital capacity, a measure of lung health, compared to a placebo. This suggests that the treatment might help manage the progression of lung fibrosis. These findings support the potential effectiveness of BMS-986278 for lung health issues related to fibrosis. ^{2 6 7 8 9}

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 adults who are not able to have children (women) or men, with a BMI of 18.0 to 32.0 and weight over 50 kg for males and over 45 kg for females. Participants must be deemed healthy based on medical history, physical exams, ECGs, and lab tests.

Inclusion Criteria

Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive

I weigh at least 50 kg if male, or 45 kg if female.

I am a healthy individual, not able to have children or a male, with normal medical exams.

Exclusion Criteria

I am a woman who can become pregnant.

Other protocol-defined Inclusion/Exclusion criteria apply

I haven't had major surgery, including GI surgery, in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986278 in a crossover design to assess comparative bioavailability

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 is testing the bioavailability of BMS-986278 in two different doses using batched methods versus a continuous method. It aims to compare the new market-ready formulation with one used in phase 3 trials among these participants.

How Is the Trial Designed?

Group I: Part 2, Sequence 2 Experimental Treatment 2 Interventions

Group II: Part 2, Sequence 1 Experimental Treatment 2 Interventions

Group III: Part 1, Sequence 2 Experimental Treatment 2 Interventions

Group IV: Part 1, Sequence 1 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

Published Research Related to This Trial

BMS-986001 was found to be safe and well tolerated in a study involving 64 healthy male subjects, with no serious adverse events reported and only 14.6% experiencing mild adverse effects that were not dose-related.

The pharmacokinetics of BMS-986001 showed a linear dose-exposure relationship, indicating consistent absorption and effectiveness across various doses, regardless of whether it was taken with or without food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, placebo-controlled single-ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of the HIV nucleoside reverse transcriptase inhibitor, BMS-986001, in healthy subjects. Urata, Y., Paintsil, E., Cheng, YC., et al.[2014]

A new high performance liquid chromatography (HPLC) method was developed to accurately measure the drug BMS182874 in mouse plasma, demonstrating high precision and accuracy with a linearity range of 100 to 1000 ng/ml.

The method showed good extraction efficiency (81-87%) and was validated for in vivo use, confirming its effectiveness in analyzing drug levels in both plasma and tissues from treated mice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of endothelin antagonist BMS182874 in plasma by high-performance liquid chromatography. Chavanpatil, MD., Rajeshkumar, NV., Gulati, A.[2007]

In a study involving 14 healthy individuals, taking BMS-284756 with a high-fat meal resulted in a 19% lower maximum plasma concentration and an 11% lower area under the plasma concentration-time curve compared to fasting, but these differences were within acceptable limits for drug efficacy.

The findings indicate that BMS-284756 is safe and well tolerated, and its efficacy is not significantly affected by food intake, allowing it to be taken without regard to meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a high-fat meal on the pharmacokinetics of the des-F(6)-quinolone BMS-284756. Gajjar, DA., Sukoneck, SC., Bello, A., et al.[2019]

The maximum tolerated dose of BMS-247550 was determined to be 40 mg/m², with manageable toxicity levels, including neutropenia and fatigue, making it a viable candidate for further testing in patients with advanced solid tumors.

At this recommended dose, BMS-247550 showed promising efficacy with partial responses in patients with ovarian and breast cancers that were resistant to other treatments, suggesting it may overcome drug resistance seen with traditional taxane therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I clinical and pharmacokinetic study of BMS-247550, a novel derivative of epothilone B, in solid tumors. Mani, S., McDaid, H., Hamilton, A., et al.[2019]

In a study involving 34 patients with advanced solid tumors, the maximum tolerated dose (MTD) of BMS-184476 was determined to be 60 mg/m2, with significant dose-limiting toxicities observed at higher doses, including severe neutropenia and diarrhea.

BMS-184476 demonstrated preliminary activity, with one patient showing a partial response and another a minor response, suggesting potential advantages over paclitaxel in terms of safety and pharmacokinetics, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel. Hidalgo, M., Aylesworth, C., Hammond, LA., et al.[2018]

Citations

1.

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 ...

2.

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.

3.

sigma.larvol.com

sigma.larvol.com/product.php?e1=747145&tab=newstrac

admilparant (BMS-986278) News

Consistent with the primary results, this analysis showed that BMS-986278 60 mg delayed time to disease progression over 26 weeks compared with placebo in ...

4.

clinicaltrials.eu

clinicaltrials.eu/inn/bms-986278/

Bms-986278 – Application in Therapy and Current ...

These trials aim to assess the drug's effectiveness, safety, and tolerability in patients with lung fibrosis, as well as its pharmacokinetics in various ...

5.

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 ...

The study showed that twice-daily administration of 60 mg of BMS-986278 over 26 weeks reduced the rate of decline in percent predicted forced vital capacity ( ...

6.

medchemexpress.com

medchemexpress.com/bms-986278.html?srsltid=AfmBOopb97glS9FmNu4k59PwLYgRd0qq_9i6xDiMniZ_An5DALeC7hGo

BMS-986278 (Admilparant) | LPA1 Antagonist

BMS-986278 is a potent and orally active lysophosphatidic acid receptor 1 (LPA1) antagonist, with Kbs of 6.9 nM and 4.0 nM for human and mouse LPA1, ...

7.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/81/NCT04308681/Prot_SAP_000.pdf

Clinical Protocol IM027040

on safety and tolerability data from the FIH study with BMS-986278. Transient, mostly asymptomatic decreases in BP were reported in the ...

8.

go.drugbank.com

go.drugbank.com/drugs/DB18011

BMS-986278: Uses, Interactions, Mechanism of Action

View sample adverse effects data in our new Data Library! See the ... Bioavailability, 1, Chemaxon. Rule of Five, Yes, Chemaxon. Ghose Filter ...

9.

delta.larvol.com

delta.larvol.com/Products/?ProductId=b69717e7-2d31-4077-b678-c46d9e656da5

admilparant (BMS-986278) / BMS

Delicious. October 07, 2025. A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac ...