BMS-986447 Safety and Tolerability for Healthy Subjects

Recruiting at 1 trial location

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

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Major surgery, Planned surgery, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

32 Participants Needed

Trial Summary

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 study is for healthy participants, it's likely that you should not be on any regular medications. Please check with the study coordinators for specific guidance.

What is the purpose of this trial?

This trial involves a new drug called BMS-986447, given as a single oral dose to healthy participants. The goal is to check if the drug is safe and how well people can tolerate it.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for healthy men and women with a body mass index (BMI) between 18 and 30. Participants must have no significant medical issues based on their history, physical exams, ECGs, or lab tests. They also need to test negative for COVID-19 before starting the study.

Inclusion Criteria

Body mass index between 18 and 30 kilograms per metered square (kg/m^2), inclusive

I am healthy with no significant medical issues based on recent exams and tests.

I have tested negative for COVID-19 as required.

Exclusion Criteria

Participant has any condition that confounds the ability to interpret data from the study

Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study

I haven't had major surgery, or plan to have any, except for GI surgery, within the last 12 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single, oral doses of BMS-986447 or placebo

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BMS-986447
• Placebo

Trial Overview The study is testing BMS-986447, which participants will take as a single oral dose. The goal is to see how safe it is, how well people can tolerate it, and how the drug levels change in the body over time. Some participants will receive a placebo instead of the actual drug.

Participant Groups

Group I: BMS-986447 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 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