BMS-984923 for Drug Interaction

Overseen By Study Recruitment Manager

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Allyx Therapeutics

No Placebo Group

Trial Summary

What is the purpose of this trial?

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. Most drugs are broken down and cleared in the body via cytochrome P450 enzymes in the liver. The metabolism and clearance of certain drugs can be affected by other drugs when dosed together. To evaluate the impact of BMS-984923 on the clearance of other medications, we will investigate three known pathways which may be impacted by BMS-984923. In this study participants will take one dose of the three known medications, midazolam, caffeine and dextromethorphan together. These drugs are known to be cleared by different cytochrome P450 enzymes. Blood will be collected to evaluate the exposure and clearance of these medications and their primary metabolites. Study participants will then be administered BMS-984923 for 18-days. On the 18th Day of BMS-984923 dosing, participants will again be co-administering midazolam, caffeine and dextromethorphan. Blood will be collected again, and the concentration of each drug will be measured. We will learn in this study if BMS-984923 changes the exposure and metabolism of the known drugs. These results will inform how BMS-984923 can be administered to patients who take multiple medications.

Eligibility Criteria

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 between 18 and 50 years old.

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

Exclusion Criteria

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

History of hypersensitivity to midazolam, caffeine, or dextromethorphan or any other formulation ingredients

Participants must test negative for caffeine prior to dosing

Treatment Details

Interventions

• BMS-984923 (Other)

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.

Participant Groups

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+