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

NCT ID: NCT05817643

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2024-11-15

Brief Summary

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

Detailed 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.

Conditions

Alzheimer Disease; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Under Fed Condition

Investigational Drug is administered with a meal

Group Type: ACTIVE_COMPARATOR

BMS-984923

Intervention Type: DRUG

Oral capsule

Dose Under Fasted Condition

Investigational Drug is administered after fasting

Group Type: ACTIVE_COMPARATOR

BMS-984923

Intervention Type: DRUG

Oral capsule

Interventions

BMS-984923

Oral capsule

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role: collaborator

Allyx Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Post, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Spaulding Clinical Research

West Bend, Wisconsin, United States

Countries

United States

Other Identifiers

ALX-923-103

Identifier Type: -

Identifier Source: org_study_id