Food Effect Study of BMS-984923 in Healthy Older Adult Vo... | NCT05817643

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

NCT05817643

Sponsor

Allyx Therapeutics

Status

Unknown status

Last Update Posted

Jul 30, 2024Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Alzheimer Disease
Dementia

Interventions

BMS-984923

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2023Actual

Primary Completion Date

Feb 27, 2023Actual

Completion Date

Nov 15, 2024Estimated

First Submitted Date

Mar 24, 2023

First Submission Date that Met QC Criteria

Apr 5, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2024

Last Update Posted Date

Jul 30, 2024Actual

Name	Class
Michael J. Fox Foundation for Parkinson's Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BMS-984923	Drug	Oral capsule	Dose Under Fasted Condition Dose Under Fed Condition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of Treatment Emergent Adverse Events (TEAE)	Safety	14 days
Safety Laboratory abnormalities	Safety	14 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Stephanie Post, MD	Principal Investigator	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Spaulding Clinical Research		West Bend	Wisconsin	53095	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies

Browse Leaves

Not provided

Browse Branches

Not provided