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Navlimetostat Metabolism Study

Recruiting at 3 trial locations
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Age: 18 - 65
Sex: Female
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb
Disqualifiers: Chronic illness, Gastrointestinal disease, others
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?

The purpose of this study is to evaluate the metabolism, the routes and extent of elimination, and drug levels of \[14C\]Navlimetostat (BMS-986504) in healthy female participants

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 healthy women who meet specific health requirements. Participants should not have any major medical conditions or be taking medications that could affect the study results.

Inclusion Criteria

Participants must have a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
I have at least one bowel movement every two days.
I am a woman who cannot become pregnant due to surgery.
See 2 more

Exclusion Criteria

I do not have any current or recent digestive system diseases.
Other protocol-defined Inclusion/Exclusion criteria apply
Participants must not have any significant acute or chronic medical illness
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive [14C]Navlimetostat (BMS-986504) to evaluate metabolism, routes and extent of elimination, and drug levels

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Navlimetostat

Trial Overview

The study tests how a single dose of Navlimetostat, labeled with a small amount of radioactive carbon ([14C]), is processed and eliminated by the body in healthy female volunteers.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part BExperimental Treatment1 Intervention
Group II: Part 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

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