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

• Sponsor: Allyx Therapeutics (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05817643
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.1
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Dementia	Drug: BMS-984923	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, 2-period, Crossover, Pilot Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers
• Actual Study Start Date: Jan 10, 2023
• Actual Primary Completion Date: Feb 27, 2023
• Anticipated Study Completion Date: May 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dose Under Fed Condition Investigational Drug is administered with a meal	Drug: BMS-984923; Oral capsule
Active Comparator: Dose Under Fasted Condition Investigational Drug is administered after fasting	Drug: BMS-984923; Oral capsule

Outcome Measures

Primary Outcome Measures

1. Maximum Plasma Concentration (Cmax) [Up to 10 days after last dose]

   Maximum plasma concentration as determined by pharmacokinetic modeling

2. Time of Cmax (Tmax) [Up to 10 days after last dose]

   Time of Cmax as determined by pharmacokinetic modeling

3. Area Under the Curve from 0 to 24h (AUC 24h) [Up to 10 days after last dose]

   Plasma drug exposure as determined by pharmacokinetic modeling

Secondary Outcome Measures

1. Incidence of Treatment Emergent Adverse Events (TEAE) [14 days]

   Safety

2. Safety Laboratory abnormalities [14 days]

   Safety

3. Electrocardiogram - QT Interval [14 days]

   Safety

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spaulding Clinical Research	West Bend	Wisconsin	United States	53095

Sponsors and Collaborators

• Allyx Therapeutics

Investigators

• Principal Investigator: Stephanie Post, MD, Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allyx Therapeutics
• ClinicalTrials.gov Identifier: NCT05817643
• Other Study ID Numbers: ALX-923-103
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 20, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease

Study Results

No Results Posted as of Apr 20, 2023