Itraconazole and Rifampin for Drug Interaction Study

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Celgene

Disqualifiers: Chronic illness, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two drugs, Itraconazole and Rifampin, affect the levels of a new medicine called AR-LDD (BMS-986365) in the body. The researchers aim to determine if taking these drugs together alters AR-LDD's effectiveness. This study targets healthy men without major illnesses or heart problems, with a BMI between 18 and 32. Participants must be able to visit a doctor and undergo tests like an ECG and lab work to confirm their health. As a Phase 1 trial, this research seeks to understand how this new treatment works in people, offering participants the opportunity to be among the first to receive it.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatment AR-LDD (also known as BMS-986365) is generally well-tolerated. While some side effects might occur, they are usually mild and manageable. Earlier studies reported low and acceptable levels of treatment-related side effects, suggesting that AR-LDD can be used safely for most participants in the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AR-LDD (BMS-986365) because it offers a unique approach to managing drug interactions, particularly with itraconazole and rifampin. Unlike current options, which may not fully address these interactions, AR-LDD is being studied for its potential to optimize dosing and improve safety when these drugs are used together. This study aims to uncover critical insights into how these drugs can be better combined, potentially leading to more effective and safer treatment protocols.

What evidence suggests that this trial's treatments could be effective?

Research has shown that AR-LDD (BMS-986365) is a promising treatment due to its mechanism of action. It targets and breaks down specific proteins that promote cancer growth. This treatment has proven effective against both regular and altered forms of these proteins. Some prostate cancer patients have benefited from it, though some experienced side effects like tiredness and dizziness at higher doses. Despite these challenges, its ability to directly target cancer cells makes it a hopeful option for future treatments. Participants in this trial will engage in various phases to assess the safety and effectiveness of AR-LDD. ^{5 6 7 8 9}

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 adult men with a BMI of 18.0 to 32.0 kg/m2 who are deemed healthy based on medical history, physical exams, vital signs, ECGs, echocardiograms, and lab tests. Participants must understand the study and agree to its terms.

Inclusion Criteria

I am a healthy male with a BMI between 18.0 and 32.0.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A, Period 1

Participants receive treatment with Itraconazole to evaluate its effect on AR-LDD drug levels

2-4 weeks

Part A, Period 2

Participants receive treatment with Rifampin to evaluate its effect on AR-LDD drug levels

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

11 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AR-LDD (BMS-986365)

Trial Overview

The study is testing how Itraconazole and Rifampin affect the levels of a drug called AR-LDD (BMS-986365) in the body. It's designed to see if these medications change how BMS-986365 works when taken together.

How Is the Trial Designed?

Group I: Part B, Period 2 Experimental Treatment 2 Interventions

Group II: Part B, Period 1 Experimental Treatment 1 Intervention

Group III: Part A, Period 2 Experimental Treatment 2 Interventions

Group IV: Part A, Period 1 Experimental Treatment 1 Intervention

Group V: Part A (Safety Lead-in Group) Experimental Treatment 2 Interventions

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

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07242781

A Study to Evaluate the Effect of Itraconazole and Rifampin ...

The purpose of this study is to evaluate the effect of Itraconazole and Rifampin on the drug levels of AR-LDD (BMS-986365) in healthy adult male ...

2.

news.bms.com

news.bms.com/news/details/2024/Bristol-Myers-Squibb-Data-at-ASCO-GU-2024-Showcase-Transformative-Research-in-the-Treatment-of-Genitourinary-Cancers/default.aspx

Bristol Myers Squibb Data at ASCO GU 2024 Showcase ...

These data demonstrate meaningful, long-term efficacy benefits seen with the combination therapy over sunitinib and reinforce it as a standard of care for ...

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championsoncology.com

championsoncology.com/hubfs/Publications/BMS2025_AR.pdf?hsLang=en

Discovery of BMS-986365, a first-in-class dual androgen ...

Results: BMS-986365 is a potent, rapid, and selective degrader of AR wildtype and most of the clinically relevant mutants. Degradation of both ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29381826/

The effect of itraconazole and rifampicin on ...

We investigated the effects of a strong CYP3A4 inhibitor (itraconazole) or inducer (rifampicin) on the pharmacokinetics of the epidermal growth factor receptor ...

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researchgate.net/publication/384147616_Safety_and_clinical_activity_of_BMS-986365_CC-94676_a_dual_androgen_receptor_ligand-directed_degrader_and_antagonist_in_heavily_pretreated_patients_with_metastatic_castration-resistant_prostate_cancer

Safety and clinical activity of BMS-986365 (CC-94676), a ...

However, higher doses led to adverse events such as fatigue, dizziness, and elevated liver enzymes. Despite these challenges, the early ...

6.

annalsofoncology.org

annalsofoncology.org/article/S0923-7534(24)04001-8/fulltext

Safety and clinical activity of BMS-986365 (CC-94676), a ...

BMS-986365 showed antitumor activity in heavily pretreated patients with mCRPC, all previously exposed to at least one ARPI. Abstract.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39293515/

Safety and clinical activity of BMS-986365 (CC-94676), a dual ...

BMS-986365 was well tolerated, with a manageable safety profile, and demonstrated activity in heavily pretreated patients with mCRPC with potentially higher ...

8.

bms.com

bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2024/asco-gu-2024-ar-ldd-phase-1-data-presentation.pdf

BMS at ASCO GU 2024 AR LDD Phase 1 Highlights

Phase 1 data supports a well tolerated & manageable safety profile. 9. Treatment-Emergent Adverse Events (TEAE). Safety Profile*. Part A, Dose.

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S0923753424040018

Safety and clinical activity of BMS-986365 (CC-94676), a ...

Overall, these data indicate that BMS986365 treatment-related toxicity was relatively low and acceptable. Rates of patients with PSA response increased dose ...