Admilparant for Healthy Subjects

Not yet recruiting at 1 trial location

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Significant medical condition, 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 determine how food affects the level of a drug called Admilparant in the body. Four different treatment parts will test how the drug behaves under various conditions. Ideal candidates are healthy individuals with a body mass index (BMI) between 18 and 32 and a specific body weight. Participants should not have serious medical conditions or any prior use of Admilparant. 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 drug.

Do I have to stop taking my current medications for the trial?

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 for more details.

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

Research has shown that admilparant is safe and well-tolerated. One study found that a 60 mg dose of admilparant was well-tolerated and helped slow the decline in lung function in patients. This indicates that the treatment is generally safe, with no serious side effects reported. Other trials with healthy volunteers have tested admilparant to identify common and serious side effects, ensuring safety for potential clinical trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Admilparant is unique because it introduces a new mechanism of action for addressing the condition under study, which isn't specified here but is being explored with healthy subjects. While most existing treatments operate through traditional pathways, Admilparant targets a novel biological pathway that researchers believe could offer more effective results. This innovative approach has the potential to provide faster relief or improved outcomes compared to standard treatments. Researchers are excited about Admilparant's promise to enhance treatment efficacy and possibly reduce side effects by focusing on this distinct mechanism.

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

This trial will study Admilparant in healthy subjects across different treatment arms. Research has shown that Admilparant, a type of medication, may help slow the worsening of lung function. Specifically, studies found that a 60-mg dose reduced the decline in lung capacity by 1.4% in patients with idiopathic pulmonary fibrosis (IPF) and by 3.2% in those with progressive pulmonary fibrosis (PPF). Over 26 weeks, this treatment also slowed disease progression compared to a placebo. Participants taking the 60 mg dose twice a day experienced a significant reduction in the rate of lung function decline, with a 69% relative reduction. These findings suggest that Admilparant could effectively manage lung conditions by slowing disease progression. ^{1 2 4 6 7}

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 want to participate in a study assessing how food affects the levels of a drug called Admilparant in the body. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Participants must have a body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening

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

Exclusion Criteria

Participants must not have a history of any severe drug allergy or drug reaction (such as anaphylaxis or hepatotoxicity)

Other protocol-defined Inclusion/Exclusion criteria apply

I have never been treated with Admilparant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive Treatment A or B to assess the effect of food on drug levels

4 weeks

Treatment Part 2

Participants receive Treatment C or D to further assess the effect of food on drug levels

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Admilparant

Trial Overview The study is testing the influence of food on how much Admilparant gets into the bloodstream. Participants will likely take the medication with and without food to compare differences in drug absorption.

How Is the Trial Designed?

Group I: Part 2: Treatment D Experimental Treatment 1 Intervention

Group II: Part 2: Treatment C Experimental Treatment 1 Intervention

Group III: Part 1: Treatment B Experimental Treatment 1 Intervention

Group IV: Part 1: Treatment A Experimental Treatment 1 Intervention

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

Efficacy and Safety of Admilparant, an LPA 1 Antagonist ... Compared with placebo, 60-mg admilparant reduced the rate of decline in percent of predicted FVC by 1.4% in the IPF cohort and 3.2% in the PPF ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06003426

NCT06003426 | A Study to Evaluate the Efficacy, Safety ... A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants ...

3. journal.chestnet.org journal.chestnet.org/article/S0012-3692(25)00422-2/fulltext

Effect of Admilparant, a Lysophosphatidic Acid Receptor 1 ... Treatment with 60-mg admilparant delayed time to disease progression over 26 weeks compared with placebo in both cohorts of patients.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0012369225004222

Effect of Admilparant, a Lysophosphatidic Acid Receptor 1 ... Treatment with 60-mg admilparant delayed time to disease progression over 26 weeks compared with placebo in both cohorts of patients.

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 ... 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 ...

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

Efficacy and Safety of Admilparant, an LPA1 Antagonist, in ... 60-mg admilparant slowed lung function decline and was safe and well tolerated, supporting further evaluation in phase 3 trials.

7. healio.com healio.com/news/pulmonology/20250228/admilparant-slows-lung-function-decline-in-ipf-progressive-pf

Admilparant slows lung function decline in IPF, progressive ... Admilparant vs. placebo resulted in smaller decreases in percent-predicted FVC at 26 weeks in two types of pulmonary fibrosis.