Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers
- Registration Number
- NCT05817643
- Lead Sponsor
- Allyx Therapeutics
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dose Under Fed Condition BMS-984923 Investigational Drug is administered with a meal Dose Under Fasted Condition BMS-984923 Investigational Drug is administered after fasting
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) Up to 10 days after last dose Maximum plasma concentration as determined by pharmacokinetic modeling
Time of Cmax (Tmax) Up to 10 days after last dose Time of Cmax as determined by pharmacokinetic modeling
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
Name Time Method Incidence of Treatment Emergent Adverse Events (TEAE) 14 days Safety
Safety Laboratory abnormalities 14 days Safety
Electrocardiogram - QT Interval 14 days Safety
Trial Locations
- Locations (1)
Spaulding Clinical Research
🇺🇸West Bend, Wisconsin, United States