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

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Primary Purpose

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-984923

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

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

NCT ID

NCT05817643

First Posted

March 24, 2023

Last Updated

October 18, 2023

Sponsor

Allyx Therapeutics

Collaborators

Michael J. Fox Foundation for Parkinson's Research

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

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

Alzheimer Disease, Dementia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial