BMS-986465 Safety Study in Healthy Subjects

No longer recruiting at 2 trial locations

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

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Major surgery, Other trial, 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 assess the safety and tolerability of a new treatment, BMS-986465, in healthy individuals. It also examines how food and other factors influence the drug's absorption in the body. Participants will be divided into groups to receive varying doses or placebos (inactive substances) for comparison. Healthy individuals without major health issues and who are not pregnant may qualify, with a specific group for those of Japanese ethnicity. 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 this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that BMS-986465 is a treatment under study to assess its safety and tolerability. Detailed safety information is currently limited. However, as it is in an early testing phase, researchers closely monitor participants' responses. This phase focuses on ensuring the treatment's safety and the body's ability to handle it.

Specific side effects may not yet be listed, but the study aims to understand how the drug interacts with food and different doses, helping to identify potential issues. If BMS-986465 had been approved for another condition, it might provide clues about its safety. For now, researchers exercise caution in these early trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BMS-986465 because it offers a fresh approach, potentially acting with a novel mechanism of action compared to standard treatments for its targeted condition. While many current treatments rely on established pathways, BMS-986465 might target different biological processes, offering a new way to tackle the condition. Additionally, the study explores different dosing strategies, including single and multiple ascending doses, which could provide insights into its optimal use and effectiveness. This could lead to more personalized treatment options and better outcomes for patients.

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

Research has shown that BMS-986465 is under investigation for its potential to treat neuroinflammation, or inflammation in the nervous system. This trial will evaluate BMS-986465 through various phases, including single and multiple ascending doses, to assess its safety in healthy subjects. The drug blocks a protein called TYK2, part of the immune system, which can cause harmful inflammation. Although limited data exists on its effectiveness in humans, its mechanism suggests it might aid conditions where neuroinflammation plays a significant role. Further research is necessary to confirm its benefits and safety for these conditions. ^{1 2 4 5 6}

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 men and women who are not able to have children, with a BMI of 18-32 and weight over 50 kg. It's open to all ethnicities, but part C specifically requires participants of Japanese descent (both parents must be ethnically Japanese).

Inclusion Criteria

Part C: Participants of Japanese ethnicity (both biological parents are ethnically Japanese)

Parts A, B, and D: Participants without restriction on ethnicity

Body Mass Index (BMI) of 18 to 32 kg/m2 and total body weight ≥ 50 kg

Exclusion Criteria

I have not had major surgery in the last 3 months.

Participation in another clinical trial concurrent with this study

Clinically significant medical, psychiatric, and/or social reasons as determined by the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive a single ascending dose of BMS-986465 or placebo to evaluate safety and tolerability

2-4 weeks

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of BMS-986465 or placebo to evaluate safety and tolerability

4-6 weeks

Food/Formulation/pH Effects

Open-label assessment of food, formulation, and pH effects on the relative bioavailability of BMS-986465 and BMS-986464

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986465

Trial Overview The study is testing BMS-986465 and its active form BMS-986464 in healthy people. They're looking at how safe it is, how the body tolerates it, and how food, different formulations, and stomach pH affect drug absorption.

How Is the Trial Designed?

Group I: Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine] Experimental Treatment 2 Interventions

Group II: Part C: MAD in Japanese ethnicity [BMS-986465 or placebo] Experimental Treatment 2 Interventions

Group III: Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys] Experimental Treatment 3 Interventions

Group IV: Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo] 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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06144697

NCT06144697 | A Study to Evaluate the Safety, Tolerability ... The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS- ...

2. withpower.com withpower.com/trial/bms-986465-safety-study-in-healthy-subjects-46b30

BMS-986465 Safety Study in Healthy Subjects The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative ...

3. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT06144697

Trial ID CN009-1024 | NCT06144697 - BMS Clinical Trials The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative ...

4. bms.com bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2024/BMY-2024-Q1-Results-Investor-Presentation-with-Appendix.pdf

Q1 2024 Results TYK2 Inhibitor (BMS-986465). ✦ Neuroinflammation Disorders. Data as of April 25th, 2024. Hematology. Neuroscience. Oncology. Immunology. CV.

5. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/bms-986465-bristol-myers-squibb-neuroinflammation-likelihood-of-approval/

BMS-986465 by Bristol-Myers Squibb for Neuroinflammation BMS-986465 is under clinical development by Bristol-Myers Squibb and currently in Phase I for Neuroinflammation.

6. focusbiomolecules.com focusbiomolecules.com/wp-content/uploads/2023/07/10-4756-Deucravicitinib-SDS.pdf

Safety Data Sheet Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust. For personal protection see section 8.