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UnknownPhase 1

Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers

A Randomized, Open-label, 2-period, Crossover, Pilot Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers

Lead sponsor

Allyx Therapeutics

Asset

BMS-984923

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 50-80

Primary endpoints

•Cmax•Time of Cmax (Tmax)•Area Under the Curve from 0 to 24h (AUC 24h)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDALX-923-103

NCT IDNCT05817643

Timeline

Milestones

Study start2023-01-10actual

Primary completion2023-02-27actual

Study first posted2023-04-18actual

Last update posted2024-07-30actual

Study completion2024-11-15estimated

Assets

Drug assets

BMS-984923

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Men or women between the ages of 50 and 80 years, inclusive

•No history of cognitive impairment

•Capable of providing written informed consent and willing to comply with all study requirements and procedures

•Participant is not pregnant, lactating, or of childbearing potential

Exclusion criteria

•Body mass index (BMI) >38 kg/m2 or body weight <50 kg.

•Significant cerebrovascular disease

•Any significant neurologic disease

•A current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V) diagnosis of active major depression, schizophrenia or bipolar disorder

•Clinically significant or unstable medical condition

•Any disorder or medication that could interfere with the absorption, distribution, metabolism or excretion of drugs

•History of cholecystectomy

•History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen [HbsAg] or anti-hepatitis C virus [HCV] antibody).

•Use of psychoactive medications

•Use of medications with potential drug-drug interactions

•Use of another investigational agent

•Clinically significant abnormalities in screening laboratories

•Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale

•Acceptable Geriatric Depression Scale (GDS) score

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Maximum Plasma Concentration (Cmax)

Time frame:Up to 10 days after last dose

concentration, descriptive

Primary/protocol endpoint

Time of Cmax (Tmax)

Time frame:Up to 10 days after last dose

concentration, descriptive

Primary/protocol endpoint

Area Under the Curve from 0 to 24h (AUC 24h)

Time frame:Up to 10 days after last dose

concentration, descriptive

Secondary/protocol endpoint

Incidence of Treatment Emergent Adverse Events (TEAE)

Time frame:14 days

event count, event

Secondary/protocol endpoint

Safety Laboratory abnormalities

Time frame:14 days

descriptive

Secondary/protocol endpoint

Electrocardiogram - QT Interval

Time frame:14 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.