Alzheimer's Disease PsychosisPhase 1NCT06793995
Effect of Food and Age on the Pharmacokinetics of LY03017
A Phase 1 study testing LY03017 in people with Alzheimer's Disease Psychosis and Parkinson Disease Psychosis, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This study consists of 2 parts. Part A is a randomized, open-label, 2-period, crossover study to evaluate the food effect of LY03017 in healthy adults. Part B is a single-arm study to evaluate the safety and pharmacokinetics of LY03017 in elderly volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease Psychosis, Parkinson Disease Psychosis, Negative Symptoms of Schizophrenia
- What is being tested?
- LY03017
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- Feb 2025to 31 Oct 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject who voluntarily participate and sign the informed consent form.
- Part A：Age ≥18 and ≤ 45 years, male and female.
- Part B：Age ≥65 years, male and female.
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and < 28.0 kg/m2.
- Able to comply with the lifestyle restrictions.
Who cannot join
- Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.
- Part A：Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders.
- Part B：Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders. Subjects with well-controlled, chronic and stable medical conditions (e.g., hypertension, type 2 diabetes, hyperlipidaemia) which are not expected to compromise subject safety or interfere with the study results will not be excluded.
- Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.
- Subject has clinically significant abnormalities in vital signs, laboratory tests, and ECGs, such as
- Pulse < 55 beats/min or > 100 beats/min,
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- Systolic blood pressure < 90 mmHg or ≥140 mmHg, Diastolic blood pressure < 60 mmHg or ≥90 mmHg,
- QT interval (QTc) ≥450 ms.
- Part B：aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or total bilirubin > 1.5 × upper limit normal (ULN), or estimated glomerular filtration rate（eGFR） <60 mL/min/1.73 m2
- Part A：Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.
- Part B：Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing, with the exception of concomitant drugs for the well-controlled, chronic and stable medical conditions.
- Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.
- Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust).
- Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results.
- Subject has a history of substance abuse within 1 year or a positive urine drug screen.
- Subject who has daily smoking of ≥ 5 cigarettes within 3 months.
- Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia.
- Subject who has consumption of special diet (such as grapefruit, chocolate, coffee, xanthine-rich foods/drinks) within 48 hours prior to dosing and/or subject who has excessive daily consumption of tea, coffee, grapefruit juice, caffeinated beverages for nearly 3 months.
- Subject who has participated in other clinical trials within 3 months before administration.
- Subject has used blood products or being blood donor or blood loss within 3 months.
- Pregnant, lactating women, or positive pregnancy test.
- Subject who refusal to contraception, or plan to donate sperm or ovums.
- Subject who has a history of needle or blood faintness.
- Subject directly involved in this clinical trial.
- Poor compliance or other conditions which would make participation in the study unsuitable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center
Shanghai
Huafang Li, 021-34773107, lhlh_5@163.com
About this study
Official title: A Phase 1 Study to Evaluate the Effect of Food and Age on the Pharmacokinetics of LPM526000133 Fumarate Capsules (LY03017) in Healthy Volunteers
This study consists of 2 parts. Part A is a randomized, open-label, 2-period, crossover study to evaluate the food effect of LY03017 in healthy adults. Part B is a single-arm study to evaluate the safety and pharmacokinetics of LY03017 in elderly volunteers.
- Conditions
- Alzheimer's Disease Psychosis, Parkinson Disease Psychosis, Negative Symptoms of Schizophrenia
- Being tested
- LY03017
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY03017Drug
single dose，administered orally for each period
LY03017Drug
single dose，administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY03017 (Part A, fasting-fed) | Experimental | Subjects will be administrated 40 mg of LY03017 under fasting conditions and fed conditions in period 1 and 2 respectively. There will be a 7-day washout period between the first and second dose. Receives: Drug: LY03017 |
| LY03017 (Part A, fed-fasting) | Experimental | Subjects will be administrated 40 mg of LY03017 under fed conditions and fasting conditions in period 1 and 2 respectively. There will be a 7-day washout period between the first and second dose. Receives: Drug: LY03017 |
| LY03017 (Part B) | Experimental | Subjects will be administrated 40 mg of LY03017 under fasting conditions on Day 1. Receives: Drug: LY03017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of LPM526000133 in plasma
Measured: Up to 96 hours after the last dose
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma
Measured: Up to 96 hours after the last dose
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma
Measured: Up to 96 hours after the last dose
Secondary outcomes (1)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 96 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease PsychosisStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793995
- Sponsor's protocol ID
- LY03017/CT-CHN-102
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Effect of Food and Age on the Pharmacokinetics of LPM526000133 Fumarate Capsules (LY03017) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06793995
- Acronym / sponsor ID
- LY03017/CT-CHN-102
- Conditions
- Alzheimer's Disease Psychosis, Parkinson Disease Psychosis, Negative Symptoms of Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 27 Jan 2025 (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 study consists of 2 parts. Part A is a randomized, open-label, 2-period, crossover study to evaluate the food effect of LY03017 in healthy adults. Part B is a single-arm study to evaluate the safety and pharmacokinetics of LY03017 in elderly volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY03017 (Part A, fasting-fed) | Experimental | Drug: LY03017Subjects will be administrated 40 mg of LY03017 under fasting conditions and fed conditions in period 1 and 2 respectively. There will be a 7-day washout period between the first and second dose. |
| LY03017 (Part A, fed-fasting) | Experimental | Drug: LY03017Subjects will be administrated 40 mg of LY03017 under fed conditions and fasting conditions in period 1 and 2 respectively. There will be a 7-day washout period between the first and second dose. |
| LY03017 (Part B) | Experimental | Drug: LY03017Subjects will be administrated 40 mg of LY03017 under fasting conditions on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject who voluntarily participate and sign the informed consent form.
- Part A：Age ≥18 and ≤ 45 years, male and female.
- Part B：Age ≥65 years, male and female.
- Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and < 28.0 kg/m2.
- Able to comply with the lifestyle restrictions.
Key exclusion criteria (25 listed)
- Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.
- Part A：Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders.
- Part B：Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders. Subjects with well-controlled, chronic and stable medical conditions (e.g., hypertension, type 2 diabetes, hyperlipidaemia) which are not expected to compromise subject safety or interfere with the study results will not be excluded.
- Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.
- Subject has clinically significant abnormalities in vital signs, laboratory tests, and ECGs, such as
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 |
|---|---|---|
| LY03017single dose，administered orally for each period | Drug | LY03017 (Part A, fasting-fed), LY03017 (Part A, fed-fasting) |
| LY03017single dose，administered orally | Drug | LY03017 (Part B) |
Primary outcome
Maximum observed concentration (Cmax) of LPM526000133 in plasma
Time frame: Up to 96 hours after the last dose
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma
Time frame: Up to 96 hours after the last dose
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma
Time frame: Up to 96 hours after the last dose
1 secondary outcome
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 96 hours after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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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.
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 LY03017 in people with Alzheimer's Disease Psychosis and Parkinson Disease Psychosis, run by Luye Pharma Group Ltd. at 1 site in China.
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 5 inclusion and 25 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: opening soon, as of the sponsor's last update on 27 Jan 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huafang Li (021-34773107, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) of LPM526000133 in plasma (time frame: Up to 96 hours after the 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 27 Jan 2025.