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

NCT05817643 | Unknown Phase 1 FDA Drug

• 1 other identifier: ALX-923-103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease; Dementia

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  Maximum plasma concentration as determined by pharmacokinetic modeling

  Up to 10 days after last dose

• Time of Cmax (Tmax)

  Time of Cmax as determined by pharmacokinetic modeling

  Up to 10 days after last dose

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

  Plasma drug exposure as determined by pharmacokinetic modeling

  Up to 10 days after last dose

Secondary Outcomes (3)

• Incidence of Treatment Emergent Adverse Events (TEAE)

  14 days

• Safety Laboratory abnormalities

  14 days

• Electrocardiogram - QT Interval

  14 days

Study Arms (2)

Dose Under Fed Condition

ACTIVE COMPARATOR

Investigational Drug is administered with a meal

Drug: BMS-984923

Dose Under Fasted Condition

ACTIVE COMPARATOR

Investigational Drug is administered after fasting

Drug: BMS-984923

Interventions

BMS-984923 DRUG

Oral capsule

Dose Under Fasted Condition; Dose Under Fed Condition

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allyx Therapeutics: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Stephanie Post, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 18, 2023
• Study Start: January 10, 2023
• Primary Completion: February 27, 2023
• Study Completion: November 15, 2024
• Last Updated: July 30, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)