BMS-986460 for Healthy Subjects

Recruiting at 1 trial location

Overseen By BMS Study Connect Contact Center, www.BMSStudyConnect.com

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Heart disease, Cardiac arrhythmias, Anaphylaxis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

56 Participants Needed

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 However, BMS-986094, another related compound, was withdrawn from trials due to unexpected heart and kidney issues. ^{1 2 3 4 5}

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

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

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

Group I: Part 2: Treatment B Experimental Treatment 1 Intervention

Group II: Part 2: Treatment A Experimental Treatment 1 Intervention

Group III: Part 2: Optional Treatment E Experimental Treatment 1 Intervention

Group IV: Part 2: Optional Treatment D Experimental Treatment 1 Intervention

Group V: Part 2: Optional Treatment C Experimental Treatment 1 Intervention

Group VI: Part 1: Sequence 3 Experimental Treatment 1 Intervention

Group VII: Part 1: Sequence 2 Experimental Treatment 1 Intervention

Group VIII: Part 1: Sequence 1 Experimental Treatment 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. England pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

From the Cover: Investigative Nonclinical Cardiovascular Safety and Toxicology Studies with BMS-986094, an NS5b RNA-Dependent RNA Polymerase Inhibitor. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Quantitative determination of BMS-378806 in human plasma and urine by high-performance liquid chromatography/tandem mass spectrometry. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

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]