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BMS-986435 for Liver Disease

No longer recruiting at 5 trial locations
BC
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Overseen ByFirst line of the email MUST contain the NCT# and Site #.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

BS

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

Participant must have body weight > 50 kg and BMI of 18.0 kg/m2 through 40 kg/m2, inclusive, at screening
My kidney function is normal based on recent blood tests.
My heart function is normal with an LVEF of 60% or higher.

Exclusion Criteria

I have not had a head injury, brain tumor, or aneurysm in the past 2 years.
Participants must not have history of or current uncontrolled or unstable clinically significant disorder, condition, or disease that would pose a risk to participant safety or interfere with study evaluation, procedures, or completion
I have no history of cancer, except certain skin or cervical cancers removed years ago.
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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 a single dose of BMS-986435 to assess pharmacokinetics and safety

1 day

Follow-up

Participants are monitored for safety and pharmacokinetic outcomes after receiving the dose

4 weeks

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

Group I: Arm CExperimental Treatment1 Intervention
Group II: Arm BExperimental Treatment1 Intervention
Group III: Arm AExperimental Treatment1 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

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