Alzheimer DiseasePhase 1NCT05817643
Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers
A Phase 1 study testing BMS-984923 in people with Alzheimer Disease and Dementia, run by Allyx Therapeutics at 1 site in United States.
Trial summary
This project is developing a novel disease-modifying compound for Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- BMS-984923
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 15 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research
West Bend, Wisconsin, 53095
About this study
Official title: A Randomized, Open-label, 2-period, Crossover, Pilot Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers
This project is developing a novel disease-modifying compound for Alzheimer's disease (AD).
Read the 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.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- BMS-984923
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-984923Drug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Dose Under Fed Condition | Active comparator | Investigational Drug is administered with a meal Receives: Drug: BMS-984923 |
| Dose Under Fasted Condition | Active comparator | Investigational Drug is administered after fasting Receives: Drug: BMS-984923 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration as determined by pharmacokinetic modeling
Measured: Up to 10 days after last dose
Time of Cmax (Tmax)
Time of Cmax as determined by pharmacokinetic modeling
Measured: 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
Measured: Up to 10 days after last dose
Secondary outcomes (3)
Incidence of Treatment Emergent Adverse Events (TEAE)
Safety
Measured: 14 days
Safety Laboratory abnormalities
Safety
Measured: 14 days
Electrocardiogram - QT Interval
Safety
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start10 Jan 2023
- Primary completion27 Feb 2023
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allyx Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Stephanie Post, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817643
- Sponsor's protocol ID
- ALX-923-103
- Status last verified
- Oct 2023
- First submitted
- 24 Mar 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, 2-period, Crossover, Pilot Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers
- ClinicalTrials.gov ID
- NCT05817643
- Acronym / sponsor ID
- ALX-923-103
- Conditions
- Alzheimer Disease, Dementia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Allyx TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Under Fed Condition | Active comparator | Drug: BMS-984923Investigational Drug is administered with a meal |
| Dose Under Fasted Condition | Active comparator | Drug: BMS-984923Investigational Drug is administered after fasting |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-984923Oral capsule | Drug | Dose Under Fasted Condition, Dose Under Fed Condition |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: Up to 10 days after last dose
Maximum plasma concentration as determined by pharmacokinetic modeling
Time of Cmax (Tmax)
Time frame: 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)
Time frame: Up to 10 days after last dose
Plasma drug exposure as determined by pharmacokinetic modeling
3 secondary outcomes
Incidence of Treatment Emergent Adverse Events (TEAE)
Time frame: 14 days
Safety Laboratory abnormalities
Time frame: 14 days
Electrocardiogram - QT Interval
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Post, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-984923 in people with Alzheimer Disease and Dementia, run by Allyx Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: Up to 10 days after last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.