64 Participants NeededMy employer runs this trial

Navlimetostat for Healthy Subjects

Recruiting at 2 trial locations
BC
Fl
Overseen ByFirst line of the email MUST contain NCT # and Site #.
Age: 18 - 65
Sex: Female
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb
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?

This trial tests a new drug, Navlimetostat, to determine how the body absorbs it in two different tablet forms. The goal is to find out if one form is more effective than the other in healthy adult women. The trial targets women who feel healthy and have no major health issues or recent stomach or gut problems. As a Phase 1 trial, this research aims to understand how Navlimetostat works in people, offering participants the opportunity to be among the first to receive this new treatment.

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. However, since the trial is for healthy participants, it's likely that you should not be on any significant medications. Please check with the trial organizers for specific guidance.

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

Research has shown that navlimetostat was generally well-tolerated in earlier studies. Participants mostly experienced mild side effects, which were not serious and easy to manage. Navlimetostat has also shown promise in treating certain types of cancer, indicating its design aims to be effective while minimizing harm. Although ongoing research continues, current evidence suggests that navlimetostat is safe for humans at the doses tested so far.12345

Why are researchers excited about this trial's treatments?

Navlimetostat is unique because it introduces a new mechanism of action for treating various conditions. While most treatments work by directly targeting symptoms or specific pathways, Navlimetostat is designed to modulate specific biological processes at the molecular level, potentially offering a more precise approach. Researchers are excited about Navlimetostat because it could lead to more effective and targeted therapies with fewer side effects, representing a significant advancement over current options.

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

Research has shown that Navlimetostat might help treat certain cancers. One study involved 179 patients taking Navlimetostat, with 94 assessed for effectiveness over six months. About 27% of these patients experienced a significant reduction in their cancer, suggesting that Navlimetostat could help control cancer growth. The drug blocks certain proteins that influence tumor growth and survival, potentially fighting cancer by altering cell behavior and growth. Participants in this trial will receive Navlimetostat in different experimental treatment arms to further evaluate its effects.12678

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 adult women who are not of childbearing potential, have a BMI between 18 and 35, normal heart tests, and good kidney and liver function. Participants must not have any significant health issues as determined by the study doctor.

Inclusion Criteria

My BMI is between 18.0 and 35.0.
I am a healthy adult female with no significant medical issues found by my doctor.
Participants must have adequate laboratory test results for renal and hepatic function, as assessed by the investigator, defined as eGFR ≥ 90 mL/min/1.73m2 using the CKD-EPI equation (screening only), and total bilirubin, ALP, GGT, AST, ALT ≤ 1.5 × ULN

Exclusion Criteria

I do not have any serious ongoing or recent medical illnesses.
I have not had serious stomach or digestive problems in the past 3 months.
Other protocol defined inclusion/exclusion criteria applies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Navlimetostat in two different tablet formulations to assess bioequivalence

2 periods

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 is testing two different tablet forms (wet-granulation vs dry-granulation) of Navlimetostat to see how the body processes each one. Only one group receives both types in a controlled setting.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Treatment BExperimental Treatment1 Intervention
Group II: Treatment 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

Citations

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