BMS-986278 Bioavailability Study in Healthy Subjects
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.12345Why 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.26789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BMS-986278 in a crossover design to assess comparative bioavailability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986278
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
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