BMS-984923 for Drug Interaction

Overseen By Study Recruitment Manager

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Allyx Therapeutics

Must not be taking: Cannabidiol, THC, Nicotine, others

Disqualifiers: Neurologic disease, Major depression, Schizophrenia, Bipolar, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the new drug, BMS-984923, affects how the body processes certain other medications. Participants will take common drugs like caffeine and midazolam before and after taking BMS-984923 to observe any changes in how the body handles these medications. The goal is to understand potential interactions between BMS-984923 and other commonly used drugs. The trial seeks individuals not currently on medication for chronic conditions who can avoid caffeine and nicotine. As a Phase 1 trial, this research focuses on understanding how BMS-984923 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current medications, as the trial excludes participants who are currently on any medication for a chronic condition or those who cannot refrain from using other prescription or non-prescription drugs.

Is there any evidence suggesting that BMS-984923 is likely to be safe for humans?

Research has shown that BMS-984923 was well-tolerated in earlier studies. In animal tests, even doses much higher than necessary did not cause significant problems, suggesting a good safety margin. Although complete data from human trials is not yet available, early results from similar studies have shown no major safety concerns. This trial is in its first phase, focusing primarily on assessing safety and side effects in humans. The treatment remains under close observation for any potential issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BMS-984923 because it offers a fresh approach to understanding drug interactions in the body. Unlike standard treatments that typically address a specific condition, BMS-984923 is being studied for its effects when combined with a cocktail of reference drugs like midazolam, caffeine, and dextromethorphan. This study aims to uncover how BMS-984923 influences the metabolism and efficacy of these commonly used substances, potentially leading to safer and more effective drug combinations in the future.

What evidence suggests that BMS-984923 might impact drug metabolism and clearance?

Research shows that BMS-984923 targets specific parts of the brain called mGluR5 receptors. This action may help address problems caused by amyloid-beta oligomers, which are linked to memory and thinking issues in conditions like Alzheimer's. Early results suggest that BMS-984923 effectively reaches its target and is safe to use. In this trial, participants will receive different dosages of BMS-984923 or a reference drug cocktail to study drug interactions. While current studies examine its interactions with other drugs, its mechanism shows promise for improving brain function. However, researchers are still learning about its effectiveness in people. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals who can safely take the medications midazolam, caffeine, and dextromethorphan together. Participants should not have any health conditions that affect drug metabolism or clearance. Specific eligibility criteria are not provided but typically include good overall health and no conflicting medications.

Inclusion Criteria

No history of cognitive impairment

I am not pregnant, not breastfeeding, and will use effective birth control during and 90 days after the trial.

I can follow the diet and medication rules of the study.

Exclusion Criteria

Positive urine drug screen or positive urine alcohol or alcohol breathalyzer test

Participants must test negative for caffeine prior to dosing

I have not had GI surgery that affects stomach movement, except for simple appendix or hernia surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-984923 for 18 days, with co-administration of midazolam, caffeine, and dextromethorphan on the 18th day

18 days

Multiple visits for blood collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• BMS-984923

Trial Overview The study tests if BMS-984923 affects how the body handles other drugs. Participants will first take a single dose of three different drugs known to be processed by liver enzymes. After taking BMS-984923 for 18 days, they'll retake the same drugs to see if their levels change in the blood.

How Is the Trial Designed?

Group I: Reference drugs cocktail Experimental Treatment 3 Interventions

midazolam, caffeine and dextromethorphan will be administered orally

Group II: 50 mg Active twice daily Experimental Treatment 1 Intervention

Group III: 50 mg Active once daily Experimental Treatment 1 Intervention

Group IV: 100 mg Active twice daily Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Allyx Therapeutics

Lead Sponsor

Trials

4

Recruited

120+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Spaulding Clinical Research LLC

Collaborator

Trials

24

Recruited

1,300+

Citations

1. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/BMS-984923_%28ALX-001%29_UPDATE_%28drug_in_development%29.pdf

BMS-984923 (ALX-001) These scientific reports include analysis of drugs, drugs-in- development, drug targets, supplements, nutraceuticals, food/drink, non-pharmacologic.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06309147

NCT06309147 | A Study to Assess the Safety of BMS- ... This double-blind placebo-controlled study will evaluate 28 days of twice daily dosing of BMS-984923 at two dose levels in comparison to placebo in ...

3. alzdiscovery.org alzdiscovery.org/uploads/cognitive_vitality_media/BMS-984923-Cognitive-Vitality-For-Researchers.pdf

Amyloid-beta oligomer receptor inhibitors (BMS-984923) These results suggest that both PrPC and mGluR5 are important for Aβo-mediated synaptic dysfunction. Finally, genetic reduction of PrPC and mGluR5 in an.

4. neurologylive.com neurologylive.com/view/alx001-advance-phase-2-studies-following-positive-phase-1b-mad-data

ALX001 to Advance to Phase 2 Studies Following Positive ... Building on positive phase 1a data, ALX-001 demonstrated target engagement of mGluR5 receptor and maintained a safe profile across multiple ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06632990

A Study Evaluating the Potential of BMS-984923 to Alter ... The goal of this study is to learn if the investigational drug, BMS-984923 will impact the exposure and clearance of other medications when given together.

6. medchemexpress.com medchemexpress.com/bms-984923.html?srsltid=AfmBOorxfKk7hiyJN5-kzOlUWqJ0Y6qXsT04MC3QwQYlfl21pSEJH-fE

BMS-984923 | mGluR5 SAM BMS-984923 potently inhibits the PrPC-mGluR5 interaction and prevents pathological Aβo signaling without affecting physiological glutamate signaling.