NCT06632990 · Phase 1 · ACTIVE NOT RECRUITING
A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates
This trial is testing whether BMS-984923, an experimental drug being developed for Alzheimer's disease, affects how the body processes other common medications. Participants take three well-known probe drugs before and after 18 days on BMS-984923, and blood samples track any changes in drug clearance. This is a Phase 1 trial — it is focused on safety and drug interactions in healthy volunteers, not on whether BMS-984923 works against any disease.
You may qualify if
- Men or women between the ages of 18 and 50 years, inclusive.
- No history of cognitive impairment.
- Capable of providing written informed consent and willing to comply with all study requirements and procedures.
- Female participants, if of childbearing potential, must be non-lactating, confirmed to be non-pregnant (negative serum pregnancy test), and agree to use a highly effective form of contraception throughout the trial and for 90 days after the last dose.
- Male participants who are sexually active with a woman of childbearing potential must agree to use condoms during the study and for 90 days after the last dose unless the woman is using a highly effective form of contraception
- Compliance with restricted foods, medications, and drinks outlined within this protocol
You're excluded if
- Currently on any medication for a chronic condition.
- Any significant neurologic disease, such as AD, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- A current DSM V diagnosis of active major depression, schizophrenia, or bipolar disorder.
- Positive urine drug screen or positive urine alcohol or alcohol breathalyzer test.
- Current use of cannabidiol / THC.
- Current nicotine use or positive urine cotinine test.
- Participants must test negative for caffeine prior to dosing.
- History of alcohol or substance abuse or dependence within the past 2 years (DSM-IV criteria).
- Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic disease that, in the opinion of the PI, may either put the participant at risk because of participation in the study, or influence the results, or the participant's ability to participate in the study.
- Any disorder or medication that could interfere with the absorption, distribution, metabolism or excretion of drugs (e.g., small bowel disease, Crohn's disease, celiac disease, GERD, or liver disease and antimotility or gastric acid depressing medications and weight loss medications)
- Surgical history of the GI tract affecting gastric motility or altering the GI tract (with the exception of uncomplicated appendectomy and hernia repair) (a cholecystectomy is exclusionary).
- Use of medications with potential drug-drug interactions
- Is unable to refrain from the use of other prescription or non-prescription drugs
- History or presence of clinically significant ECG abnormalities
- Donation of blood or blood products for transfusion within 3 months prior to first study drug administration
- History of hypersensitivity to any of the excipients in the formulation of the study drugs.
- History of hypersensitivity to midazolam, caffeine, or dextromethorphan or any other formulation ingredients.
- Use of another investigational agent within 30 days or 5 half-lives
- Neutropenia
- Thrombocytopenia
- Has moderate or severe renal disease
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-02-07