56 Participants Needed

BMS-986460 for Healthy Subjects

Recruiting at 1 trial location
Fl
BS
Overseen ByBMS Study Connect Contact Center, www.BMSStudyConnect.com
Age: 18 - 65
Sex: Male
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 trial is for healthy participants, it's possible that taking medications could affect eligibility. Please consult with the trial coordinator for specific guidance.

Is BMS-986460 safe for humans?

There is no specific safety data available for BMS-986460, but similar compounds like BMS-986001 and BMS-378806 were generally safe and well tolerated in healthy subjects. However, BMS-986094, another related compound, was withdrawn from trials due to unexpected heart and kidney issues.12345

What is the purpose of this trial?

The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants.

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for healthy adult men who can participate in a study to test different forms of a drug called BMS-986460. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive
I agree to use birth control if I'm sexually active with someone who can get pregnant.
I am generally healthy with no significant medical issues.

Exclusion Criteria

Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded
Other protocol-defined Inclusion/Exclusion criteria apply
Participants with history of anaphylactic reactions are excluded
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Treatment

Evaluation of relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants

4 weeks

Part 2: Single Ascending Dose Study

Evaluation of safety, tolerability, and pharmacokinetics of BMS-986460 in healthy adult male participants

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • BMS-986460
Trial Overview The study is testing the safety and how the body absorbs different versions of BMS-986460. It's a single-dose trial, meaning each participant will receive one dose of the medication to evaluate its effects.
Participant Groups
8Treatment groups
Experimental Treatment
Group I: Part 2: Treatment BExperimental Treatment1 Intervention
Group II: Part 2: Treatment AExperimental Treatment1 Intervention
Group III: Part 2: Optional Treatment EExperimental Treatment1 Intervention
Group IV: Part 2: Optional Treatment DExperimental Treatment1 Intervention
Group V: Part 2: Optional Treatment CExperimental Treatment1 Intervention
Group VI: Part 1: Sequence 3Experimental Treatment1 Intervention
Group VII: Part 1: Sequence 2Experimental Treatment1 Intervention
Group VIII: Part 1: Sequence 1Experimental 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

Findings from Research

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]
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]

References

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]
Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel. [2018]
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]
In Vitro Metabolite Formation in Human Hepatocytes and Cardiomyocytes and Metabolism and Tissue Distribution in Monkeys of the 2'-C-Methylguanosine Prodrug BMS-986094 : Potential Role in Clinical Cardiovascular Toxicity. [2022]
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