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
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.
- 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