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

• Status: Active, not recruiting
• Trial end date: 2023-05-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Allyx Therapeutics

Criteria

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