Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632990
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None