Effect of Food and Age on the Pharmacokinetics of LY03017

NCT06793995 | Not Yet Recruiting Phase 1

• 1 other identifier: LY03017/CT-CHN-102
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease Psychosis; Parkinson Disease Psychosis; Negative Symptoms of Schizophrenia

Outcome Measures

Primary Outcomes (3)

• Maximum observed concentration (Cmax) of LPM526000133 in plasma

  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

  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

  Up to 96 hours after the last dose

Secondary Outcomes (1)

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  Up to 96 hours after the last dose

Study Arms (3)

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.

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.

Drug: LY03017

LY03017 (Part B)

EXPERIMENTAL

Subjects will be administrated 40 mg of LY03017 under fasting conditions on Day 1.

Drug: LY03017

Interventions

LY03017 DRUG

single dose，administered orally for each period

LY03017 (Part A, fasting-fed); LY03017 (Part A, fed-fasting)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

Central Study Contacts

Huafang Li

CONTACT

021-34773107; lhlh_5@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: February 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

CN (1)