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NCT06632990 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates
A Phase 1 study of Drug-Drug Interaction (DDI), sponsored by Allyx Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06632990: Active Phase 1 study of Drug-Drug Interaction (DDI), sponsored by Allyx Therapeutics.
NCT06632990 is a Phase 1 study of Drug-Drug Interaction (DDI) that is active but no longer recruiting, run by Allyx Therapeutics. The registered enrollment target is 36 participants, below the 45-participant average among 3 other Drug-Drug Interaction (DDI) trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06632990, a Phase 1 study of Drug-Drug Interaction (DDI), is active but no longer recruiting, sponsored by Allyx Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Total plasma concentration of caffeine as determined by pharmacokinetic modeling
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Caffeine
- DRUG BMS-984923
- DRUG dextromethorphan
Study Locations (1)
Wisconsin
- Spaulding Clinical Research - West Bend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-11-04 |
| Est. Completion | 2025-10-15 |
| Phase | Phase 1 |
What the registry record for NCT06632990 still lists
NCT06632990 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 45-participant average among 3 other Drug-Drug Interaction (DDI) trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Drug-Drug Interaction (DDI) appearing as the primary indexed condition, and to 4 interventions - of which Midazolam is the first listed.
NCT06632990 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT06632990 about?
NCT06632990 is a clinical study titled "A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates". 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 b...
What is the current status of trial NCT06632990?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2024-11-04. Estimated completion is 2025-10-15.
What conditions does trial NCT06632990 study?
This clinical trial studies the following conditions: Drug-Drug Interaction (DDI).
What interventions are being tested in trial NCT06632990?
The interventions under investigation include: Midazolam (DRUG), Caffeine (DRUG), BMS-984923 (DRUG), dextromethorphan (DRUG).
Who is sponsoring clinical trial NCT06632990?
This trial is sponsored by Allyx Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06632990 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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