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

Allyx Therapeutics

Status and phase

Active, not recruiting

Phase 1

Conditions

Alzheimer Disease

Dementia

Treatments

Drug: BMS-984923

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05817643

ALX-923-103

Details and patient eligibility

About

This project is developing a novel disease-modifying compound for Alzheimer's disease (AD).

Full description

The primary objective of this study is to evaluate for an effect of food consumption on the pharmacokinetics profile of BMS984923. Safety and tolerability is also assessed.

Enrollment

12 patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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