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BMS-984923 for Drug Interaction
Phase 1
Waitlist Available
Research Sponsored by Allyx Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men or women between the ages of 18 and 50 years, inclusive
Be between 18 and 65 years old
Must not have
Current use of cannabidiol / THC
A current DSM V diagnosis of active major depression, schizophrenia, or bipolar disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up last 96 hours
Awards & highlights
No Placebo-Only Group
Summary
"This trial is looking at how a new drug, BMS-984923, may affect the way other medications are broken down and cleared by the body. Participants will take three different medications and then B
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects aren't detailed here, but common reactions might include issues related to liver function changes due to enzyme interaction from BMS-984923 or typical side effects from midazolam (drowsiness), caffeine (jitters), and dextromethorphan (nausea).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently using CBD or THC products.
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I have been diagnosed with major depression, schizophrenia, or bipolar disorder.
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I have a low platelet count.
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I have a low white blood cell count.
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I have moderate or severe kidney disease.
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I do not have major neurological conditions like Alzheimer's, Parkinson's, or MS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ last 96 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~last 96 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area under the curve for the first and last 96 hours of dosing (AUC96h) as determined by PK modeling
Area under the curve for the last 96 hours of dosing (AUC96h)
Trough plasma drug concentration at steady state
Secondary study objectives
Incidence of clinically significant changes in safety assessments vital signs, physical exam, electrocardiogram
Incidence of clinically significant lab abnormalities
Incidence of treatment-emergent adverse events (TEAEs) Safety
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Reference drugs cocktailExperimental Treatment3 Interventions
midazolam, caffeine and dextromethorphan will be administered orally
Group II: 50 mg Active twice dailyExperimental Treatment1 Intervention
Group III: 50 mg Active once dailyExperimental Treatment1 Intervention
Group IV: 100 mg Active twice dailyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dextromethorphan
2012
Completed Phase 4
~310
Midazolam
2018
Completed Phase 4
~1910
BMS-984923
2021
Completed Phase 1
~40
Caffeine
2014
Completed Phase 3
~2980
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,805 Previous Clinical Trials
28,194,821 Total Patients Enrolled
Spaulding Clinical Research LLCOTHER
23 Previous Clinical Trials
1,297 Total Patients Enrolled
Allyx TherapeuticsLead Sponsor
3 Previous Clinical Trials
80 Total Patients Enrolled