102 Participants Needed

BMS-986365 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: Celgene
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for this trial?

The protocol does not specify if you need to stop taking your current medications, but since the trial is for healthy subjects, you likely shouldn't be on any significant medications.

What data supports the idea that BMS-986365 for Healthy Subjects is an effective drug?

The available research does not provide any data specifically about BMS-986365, also known as CC-94676 or Gridegalutamide, being an effective treatment. The studies mentioned focus on other drugs and treatments for glioblastoma, such as DTCM-glutarimide, glufosfamide, bombesin/gastrin-releasing peptide antagonists, and cilengitide. These studies explore different approaches to treating glioblastoma, but none of them mention BMS-986365 or provide data on its effectiveness.12345

What safety data is available for BMS-986365, CC-94676, or Gridegalutamide?

The provided research does not contain safety data for BMS-986365, CC-94676, or Gridegalutamide. The studies mentioned focus on different compounds, such as BMS-986001, SAR425899, MK-5046, BMS-275183, and semaglutide, none of which are related to the compounds in question.678910

Is the drug BMS-986365 a promising treatment for healthy subjects?

The information provided does not mention BMS-986365 or its potential as a treatment. Therefore, we cannot determine if BMS-986365 is promising based on the given data.68111213

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy 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 assess the safety of a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conflicting medical conditions.

Inclusion Criteria

Healthy adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator
Body mass index (BMI) of 18.0 to 32.0 kg/m^2, inclusive

Exclusion Criteria

I do not have any serious long-term or sudden illnesses.
I have a history of serious heart conditions.
Other protocol-defined inclusion/exclusion criteria apply
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single ascending doses of BMS-986365 to evaluate safety, tolerability, and pharmacokinetics

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • BMS-986365
Trial Overview The study is testing BMS-986365, possibly a new drug, looking at how safe it is and how the body processes it. It will also compare the effects of taking it with food versus without and its bioavailability compared to Rabeprazole.
Participant Groups
11Treatment groups
Experimental Treatment
Group I: Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365Experimental Treatment2 Interventions
Group II: Part 2: Cohort 4 BMS-986365 Dose 9 FastedExperimental Treatment1 Intervention
Group III: Part 2: Cohort 4 BMS-986365 Dose 10 FedExperimental Treatment1 Intervention
Group IV: Part 1: Cohort 9 BMS-986365 Dose 8Experimental Treatment1 Intervention
Group V: Part 1: Cohort 8 BMS-986365 Dose 7Experimental Treatment1 Intervention
Group VI: Part 1: Cohort 7 BMS-986365 Dose 6Experimental Treatment1 Intervention
Group VII: Part 1: Cohort 6 BMS-986365 Dose 5Experimental Treatment1 Intervention
Group VIII: Part 1: Cohort 3 BMS-986365 Dose 4Experimental Treatment1 Intervention
Group IX: Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2Experimental Treatment1 Intervention
Group X: Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1Experimental Treatment1 Intervention
Group XI: Part 1: Cohort 1 BMS-986365 Dose 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials
649
Recruited
130,000+
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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

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Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Findings from Research

DTCM-g, a new anti-inflammatory compound, effectively impairs the growth and invasion of glioblastoma (GBM) cells in both pediatric and adult models, showing potential as an adjuvant treatment.
The compound also enhances the effectiveness of radiation therapy, indicating that it could improve treatment outcomes for GBM patients when used in combination with existing therapies.
DTCM-glutarimide Delays Growth and Radiosensitizes Glioblastoma.Roberto, GM., Paiva, HH., Botelho de Souza, LE., et al.[2019]
In a phase II trial involving 31 patients with recurrent glioblastoma multiforme, glufosfamide demonstrated modest toxicity but did not show significant clinical antitumor activity, with no objective responses observed.
Only one patient (3%) remained progression-free at 6 months, indicating that glufosfamide may not be an effective treatment option for this type of brain cancer.
European Organization for Research and Treatment of Cancer (EORTC) open label phase II study on glufosfamide administered as a 60-minute infusion every 3 weeks in recurrent glioblastoma multiforme.van den Bent, MJ., Grisold, W., Frappaz, D., et al.[2022]
The bombesin/GRP antagonists RC-3940-II and RC-3940-Et significantly reduced the growth of U-118MG human malignant glioma tumors in nude mice by 52.5% and 72.6%, respectively, over 6 weeks of treatment.
Both antagonists effectively induced apoptosis in tumor cells, as evidenced by a 70% reduction in the Bcl-2:Bax ratio and a significant decrease in VEGF and PKC-alpha levels, suggesting their potential as effective treatments for glioblastomas.
Antagonists of bombesin/gastrin-releasing peptide decrease the expression of angiogenic and anti-apoptotic factors in human glioblastoma.Kanashiro, CA., Schally, AV., Cai, RZ., et al.[2019]

References

DTCM-glutarimide Delays Growth and Radiosensitizes Glioblastoma. [2019]
European Organization for Research and Treatment of Cancer (EORTC) open label phase II study on glufosfamide administered as a 60-minute infusion every 3 weeks in recurrent glioblastoma multiforme. [2022]
Antagonists of bombesin/gastrin-releasing peptide decrease the expression of angiogenic and anti-apoptotic factors in human glioblastoma. [2019]
Cilengitide modulates attachment and viability of human glioma cells, but not sensitivity to irradiation or temozolomide in vitro. [2021]
Cilengitide response in ultra-low passage glioblastoma cell lines: relation to molecular markers. [2021]
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]
A novel dual glucagon-like peptide and glucagon receptor agonist SAR425899: Results of randomized, placebo-controlled first-in-human and first-in-patient trials. [2019]
Pharmacokinetics and pharmacodynamics of MK-5046, a bombesin receptor subtype-3 (BRS-3) agonist, in healthy patients. [2021]
Phase I trial with BMS-275183, a novel oral taxane with promising antitumor activity. [2016]
Gastrointestinal tolerability of once-weekly semaglutide 2.4 mg in adults with overweight or obesity, and the relationship between gastrointestinal adverse events and weight loss. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Effect of food on the pharmacokinetic behavior of the potent oral taxane BMS-275183. [2016]
12.United Statespubmed.ncbi.nlm.nih.gov
Identification and Characterization of BMS-955176, a Second-Generation HIV-1 Maturation Inhibitor with Improved Potency, Antiviral Spectrum, and Gag Polymorphic Coverage. [2022]
Lack of effect of food on the steady state pharmacokinetics of BMS-181101, an antidepressant, in healthy subjects. [2019]
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