BMS-986435 for Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BMS-986435 to evaluate its movement through the body and its safety for individuals with liver disease. The study will include participants with mild and moderate liver problems, as well as those with normal liver function for comparison. It aims to better understand how the medication affects individuals with varying liver function levels. Candidates may qualify if they have liver issues but no serious heart conditions, and maintain a healthy weight and kidney function. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that BMS-986435 is likely to be safe for humans?
Studies of BMS-986435 have suggested that it is safe in controlled settings. This treatment is being tested for individuals with heart failure and liver conditions. So far, patients have tolerated it well, and no major side effects have been reported. However, liver problems can affect drug efficacy and safety, making it crucial to monitor liver function when testing new treatments like BMS-986435. Participants in a clinical trial will have their side effects closely monitored by researchers to ensure safety.12345
Why do researchers think this study treatment might be promising for liver disease?
BMS-986435 is unique because it targets liver disease with a novel mechanism of action, potentially offering better outcomes for patients with varying degrees of hepatic impairment. Current treatments often focus on managing symptoms rather than addressing underlying causes. Researchers are excited about BMS-986435 because it could improve liver function more directly, offering a targeted approach for both mild and moderate hepatic impairment. This specificity in targeting liver function could lead to more effective and personalized treatment options compared to standard therapies.
What evidence suggests that BMS-986435 might be an effective treatment for liver disease?
This trial will evaluate BMS-986435 for liver disease across different levels of hepatic function. Research suggests that BMS-986435 could aid liver disease by targeting liver function. The treatment aims to improve liver health by focusing on specific liver processes. Although direct evidence on BMS-986435's effectiveness is limited, similar drugs have shown promise in treating liver conditions like non-alcoholic steatohepatitis (NASH), a type of fatty liver disease. This suggests that BMS-986435 might work similarly. More studies are needed to confirm its benefits, but the approach appears promising based on its intended mechanism in the body.678910
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 adults who are either healthy or have liver disease, with a normal heart function, body weight over 50 kg, BMI between 18 and 40, and good kidney function. People with heart problems or poor kidney health cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of BMS-986435 to assess pharmacokinetics and safety
Follow-up
Participants are monitored for safety and pharmacokinetic outcomes after receiving the dose
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986435
Trial Overview
The study is testing how the drug BMS-986435 behaves in the body and its safety in people with normal liver function compared to those with different levels of liver impairment.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Matched participants with normal hepatic function
Moderate Hepatic Impairment
Mild Hepatic Impairment
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
Citations
NCT04267393 | Safety and Effectiveness of BMS-986263 ...
The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease)
Comparative efficacy of multiple drugs for non-alcoholic fatty ...
The study outcomes included anthropometric measurements, biological markers, hepatic fat content, and liver biopsy results. The protocol for ...
Corporate news details
Bristol-Myers Squibb Company (NYSE:BMY) today announced that new data across serious liver diseases, including nonalcoholic steatohepatitis ...
Liver Disease Clinical Trials
The purpose of this study is to create a resource of data to better understand PBC, PSC, and controls from Mayo Clinic patients and non-Mayo Clinic Patients.
5.
ohioclinicaltrials.com
ohioclinicaltrials.com/understanding-liver-impairment-clinical-trials-how-research-is-advancing-treatment-options/Understanding Liver Impairment Clinical Trials
By testing new treatments, exploring the mechanisms behind liver disease, and advancing our understanding of how the liver functions, clinical ...
6.
clinicaltrials.eu
clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-bms-986435-in-patients-with-heart-failure-with-preserved-ejection-fraction-hfpef/Study on the Safety and Tolerability of BMS-986435 in ...
This clinical trial is focused on studying a condition known as Heart Failure with Preserved Ejection Fraction (HFpEF).
Hepatic Impairment as a Risk Factor for Drug Safety - PMC - NIH
Hepatic impairment (HI) influences the pharmacokinetics and pharmacodynamics of drugs and represents an important risk factor for drug safety.
Trial ID CV029-1001 | NCT06122779 - BMS Clinical Trials
The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart ...
NCT03486912 | A Study of Experimental Medication BMS- ...
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver)
Advanced Research in Liver Disease
Bristol Myers Squibb's research in liver disease began more than 15 years ago, paving the way for a new era in viral hepatitis treatment.
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