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

Primary Purpose

Alzheimer Disease, Dementia

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-984923
Sponsored by
Allyx Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Spaulding Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dose Under Fed Condition

Dose Under Fasted Condition

Arm Description

Investigational Drug is administered with a meal

Investigational Drug is administered after fasting

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax)
Maximum plasma concentration as determined by pharmacokinetic modeling
Time of Cmax (Tmax)
Time of Cmax as determined by pharmacokinetic modeling
Area Under the Curve from 0 to 24h (AUC 24h)
Plasma drug exposure as determined by pharmacokinetic modeling

Secondary Outcome Measures

Incidence of Treatment Emergent Adverse Events (TEAE)
Safety
Safety Laboratory abnormalities
Safety
Electrocardiogram - QT Interval
Safety

Full Information

First Posted
March 24, 2023
Last Updated
October 18, 2023
Sponsor
Allyx Therapeutics
Collaborators
Michael J. Fox Foundation for Parkinson's Research
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1. Study Identification

Unique Protocol Identification Number
NCT05817643
Brief Title
Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers
Official Title
A Randomized, Open-label, 2-period, Crossover, Pilot Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
February 27, 2023 (Actual)
Study Completion Date
June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allyx Therapeutics
Collaborators
Michael J. Fox Foundation for Parkinson's Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Under Fed Condition
Arm Type
Active Comparator
Arm Description
Investigational Drug is administered with a meal
Arm Title
Dose Under Fasted Condition
Arm Type
Active Comparator
Arm Description
Investigational Drug is administered after fasting
Intervention Type
Drug
Intervention Name(s)
BMS-984923
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)
Description
Maximum plasma concentration as determined by pharmacokinetic modeling
Time Frame
Up to 10 days after last dose
Title
Time of Cmax (Tmax)
Description
Time of Cmax as determined by pharmacokinetic modeling
Time Frame
Up to 10 days after last dose
Title
Area Under the Curve from 0 to 24h (AUC 24h)
Description
Plasma drug exposure as determined by pharmacokinetic modeling
Time Frame
Up to 10 days after last dose
Secondary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events (TEAE)
Description
Safety
Time Frame
14 days
Title
Safety Laboratory abnormalities
Description
Safety
Time Frame
14 days
Title
Electrocardiogram - QT Interval
Description
Safety
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Post, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Clinical Research
City
West Bend
State/Province
Wisconsin
ZIP/Postal Code
53095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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