74 Participants Needed

BMS-986419 for Healthy Subjects

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BS
Overseen ByBMS Study Connect Contact Center www.BMSStudyConnect.com
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of BMS-986419 (Part 1) and the effects of multiple doses of BMS-986419 on cardiac repolarization (Part 2) in healthy participants.

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 team for specific guidance.

What safety data exists for BMS-986419 in humans?

There is no specific safety data available for BMS-986419, but similar compounds like BMS-986001 and BMS-378806 have been studied. BMS-986001 was generally safe and well tolerated in healthy subjects, while BMS-378806 was also safe over a range of doses. However, BMS-986094, another related compound, was withdrawn due to unexpected heart and kidney issues in animal studies.12345

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 individuals with a BMI between 18.0 and 30.0 kg/m^2. They must pass medical history reviews, physical exams, vital sign checks, ECGs, and lab tests to confirm their health status.

Inclusion Criteria

My BMI is between 18.0 and 30.0.
I am healthy based on recent medical exams and tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive BMS-986419 or placebo to assess safety, tolerability, and pharmacokinetics

3 weeks
Multiple visits (in-person)

Treatment Part 2

Participants receive multiple doses of BMS-986419 to evaluate effects on cardiac repolarization

2 weeks
Multiple 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-986419
Trial Overview The study is testing BMS-986419's safety and how the body processes it (Part 1), as well as its effects on heart electrical activity after multiple doses (Part 2). Participants may receive the actual drug or placebos.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: Group 2bExperimental Treatment3 Interventions
Group II: Part 2: Group 2aExperimental Treatment3 Interventions
Group III: Part 2: Group 1Experimental Treatment3 Interventions
Group IV: Part 1: Administration of BMS-986419Experimental Treatment1 Intervention
Group V: Part 1: Administration of PlaceboPlacebo Group1 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

Published Research Related to This Trial

In a study involving 34 patients with advanced solid tumors, the maximum tolerated dose (MTD) of BMS-184476 was determined to be 60 mg/m2, with significant dose-limiting toxicities observed at higher doses, including severe neutropenia and diarrhea.
BMS-184476 demonstrated preliminary activity, with one patient showing a partial response and another a minor response, suggesting potential advantages over paclitaxel in terms of safety and pharmacokinetics, warranting further investigation.
Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel.Hidalgo, M., Aylesworth, C., Hammond, LA., et al.[2018]
PD 0348292 was found to be well tolerated in healthy subjects during phase 1 studies, with only minor bleeding-related adverse events noted after multiple doses, indicating a favorable safety profile.
The drug demonstrated robust inhibition of thrombin generation in a concentration-dependent manner, suggesting its potential efficacy in managing coagulation, with pharmacokinetic properties supporting further clinical development.
Safety, pharmacokinetics, and pharmacodynamics of PD 0348292, an oral, direct factor Xa inhibitor, after single and multiple dosings in healthy subjects.Xuan, D., McBride, S., Wastall, P., et al.[2018]
BMS-986001 was found to be safe and well tolerated in a study involving 64 healthy male subjects, with no serious adverse events reported and only 14.6% experiencing mild adverse effects that were not dose-related.
The pharmacokinetics of BMS-986001 showed a linear dose-exposure relationship, indicating consistent absorption and effectiveness across various doses, regardless of whether it was taken with or without food.
Randomized, placebo-controlled single-ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of the HIV nucleoside reverse transcriptase inhibitor, BMS-986001, in healthy subjects.Urata, Y., Paintsil, E., Cheng, YC., et al.[2014]

Citations

Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel. [2018]
Safety, pharmacokinetics, and pharmacodynamics of PD 0348292, an oral, direct factor Xa inhibitor, after single and multiple dosings in healthy subjects. [2018]
Randomized, placebo-controlled single-ascending-dose study to evaluate the safety, tolerability and pharmacokinetics of the HIV nucleoside reverse transcriptase inhibitor, BMS-986001, in healthy subjects. [2014]
From the Cover: Investigative Nonclinical Cardiovascular Safety and Toxicology Studies with BMS-986094, an NS5b RNA-Dependent RNA Polymerase Inhibitor. [2022]
Quantitative determination of BMS-378806 in human plasma and urine by high-performance liquid chromatography/tandem mass spectrometry. [2019]
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