Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants

Recruiting at 1 trial location

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: Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.

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 weigh at least 45 kg with a BMI between 18 and 32. Participants must have no significant health issues as confirmed by medical history, physical exams, heart tests (ECG), lab assessments, and must have normal heart pumping function.

Inclusion Criteria

My weight is at least 45 kg and my BMI is between 18 and 32.

I am generally healthy based on recent medical exams.

My heart's pumping ability is good and I have no major heart issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single doses of BMS-986435 in a three-way crossover design to assess relative bioavailability

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986435

Trial Overview The study is testing the absorption of different tablet forms of BMS-986435 in men and women to see how well they work and if there are any differences between them.

How Is the Trial Designed?

Group I: Treatment C: BMS-986435 Test Dose 2 Experimental Treatment 1 Intervention

Group II: Treatment B: BMS-986435 Test Dose 1 Experimental Treatment 1 Intervention

Group III: Treatment A: BMS-986435 Reference Dose 1 Active Control 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