NCT06632990

A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates

An Open-label, Randomized, Three-arm Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates in Healthy Adult Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Allyx Therapeutics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

To expand the use of concomitant medications in the future, the Sponsor is performing the clinical trial ALX-923-108 to determine the net effect (inhibition and induction) of BMS-984923 repeat dosing at 3 different clinically relevant doses of BMS-984923 on the pharmacokinetics of the sensitive cytochrome P450 probe substrates caffeine (CYP1A2), dextromethorphan (CYP2D6), and midazolam (CYP3A4) and their respective metabolites as measured by systemic exposure of each probe.

Conditions

• Drug Drug Interaction (DDI)

Interventions

Type	Name	Description
DRUG	BMS-984923	oral capsules once or twice daily
DRUG	Midazolam	midazolam, oral, 2mg administered before study drug and after study drug
DRUG	Caffeine	Caffeine, oral, 100mg administered before study drug and after study drug
DRUG	dextromethorphan	dextromethorphan, oral, 30mg administered before study drug and after study drug

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-04-03
• Completion: 2025-10-15
• First posted: 2024-10-09
• Last updated: 2025-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study