BMS-986465 Safety Study in Healthy Subjects

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

267 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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-986464 in healthy participants and healthy participants of Japanese ethnicity.

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