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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05817643
• Other study ID #: ALX-923-103
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 10, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: October 2023
• Source: Allyx Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 15, 2024
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Drug:
• BMS-984923
Oral capsule

Locations

Country	Name	City	State
United States	Spaulding Clinical Research	West Bend	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Allyx Therapeutics	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)	Maximum plasma concentration as determined by pharmacokinetic modeling	Up to 10 days after last dose
Primary	Time of Cmax (Tmax)	Time of Cmax as determined by pharmacokinetic modeling	Up to 10 days after last dose
Primary	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	Incidence of Treatment Emergent Adverse Events (TEAE)	Safety	14 days
Secondary	Safety Laboratory abnormalities	Safety	14 days
Secondary	Electrocardiogram - QT Interval	Safety	14 days