BMS-986278 Bioavailability Study in Healthy Subjects

Recruiting at 1 trial location

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Chronic illness, Recent GI disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 periods

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a trial to evaluate the comparative bioavailability of BMS-986278 to-be-marketed formulation compared to the phase 3 clinical trial formulation 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 trial is for healthy participants, it's likely that you should not be on any significant medications.

What safety data exists for BMS-986278 in humans?

There is no specific safety data available for BMS-986278, but a similar compound, BMS-986001, was tested in healthy subjects and was generally safe and well tolerated with no serious side effects. ^{1 2 3 4 5}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for healthy adults who are not able to have children (women) or men, with a BMI of 18.0 to 32.0 and weight over 50 kg for males and over 45 kg for females. Participants must be deemed healthy based on medical history, physical exams, ECGs, and lab tests.

Inclusion Criteria

Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive

I weigh at least 50 kg if male, or 45 kg if female.

I am a healthy individual, not able to have children or a male, with normal medical exams.

Exclusion Criteria

I am a woman who can become pregnant.

Other protocol-defined Inclusion/Exclusion criteria apply

I haven't had major surgery, including GI surgery, in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986278 in a crossover design to assess comparative bioavailability

4 periods

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986278

Trial Overview The study is testing the bioavailability of BMS-986278 in two different doses using batched methods versus a continuous method. It aims to compare the new market-ready formulation with one used in phase 3 trials among these participants.

How Is the Trial Designed?

Group I: Part 2, Sequence 2 Experimental Treatment 2 Interventions

Group II: Part 2, Sequence 1 Experimental Treatment 2 Interventions

Group III: Part 1, Sequence 2 Experimental Treatment 2 Interventions

Group IV: Part 1, Sequence 1 Experimental Treatment 2 Interventions

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

Published Research Related to This Trial

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]

A new high performance liquid chromatography (HPLC) method was developed to accurately measure the drug BMS182874 in mouse plasma, demonstrating high precision and accuracy with a linearity range of 100 to 1000 ng/ml.

The method showed good extraction efficiency (81-87%) and was validated for in vivo use, confirming its effectiveness in analyzing drug levels in both plasma and tissues from treated mice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of endothelin antagonist BMS182874 in plasma by high-performance liquid chromatography. Chavanpatil, MD., Rajeshkumar, NV., Gulati, A.[2007]

In a study involving 14 healthy individuals, taking BMS-284756 with a high-fat meal resulted in a 19% lower maximum plasma concentration and an 11% lower area under the plasma concentration-time curve compared to fasting, but these differences were within acceptable limits for drug efficacy.

The findings indicate that BMS-284756 is safe and well tolerated, and its efficacy is not significantly affected by food intake, allowing it to be taken without regard to meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a high-fat meal on the pharmacokinetics of the des-F(6)-quinolone BMS-284756. Gajjar, DA., Sukoneck, SC., Bello, A., et al.[2019]

The maximum tolerated dose of BMS-247550 was determined to be 40 mg/m², with manageable toxicity levels, including neutropenia and fatigue, making it a viable candidate for further testing in patients with advanced solid tumors.

At this recommended dose, BMS-247550 showed promising efficacy with partial responses in patients with ovarian and breast cancers that were resistant to other treatments, suggesting it may overcome drug resistance seen with traditional taxane therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I clinical and pharmacokinetic study of BMS-247550, a novel derivative of epothilone B, in solid tumors. Mani, S., McDaid, H., Hamilton, A., et al.[2019]

Citations

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. Germany pubmed.ncbi.nlm.nih.gov

Determination of endothelin antagonist BMS182874 in plasma by high-performance liquid chromatography. [2007]

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

Effect of a high-fat meal on the pharmacokinetics of the des-F(6)-quinolone BMS-284756. [2019]

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

Phase I clinical and pharmacokinetic study of BMS-247550, a novel derivative of epothilone B, in solid tumors. [2019]