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

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

Detailed Description
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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.

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

Conditions
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Alzheimer Disease, Dementia

Intervention / Treatment
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* Drug: BMS-984923


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dose Under Fed Condition<br>Investigational Drug is administered with a meal | Drug: BMS-984923<br>* Oral capsule<br>|
| Active Comparator: Dose Under Fasted Condition<br>Investigational Drug is administered after fasting | Drug: BMS-984923<br>* Oral capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Emergent Adverse Events (TEAE) | Safety | 14 days | 
| Safety Laboratory abnormalities | Safety | 14 days | 
| Electrocardiogram - QT Interval | Safety | 14 days |