Effect of Food and Age on the Pharmacokinetics of LY03017

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

Overview

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.

Interventions

• Drug LY03017
  single dose，administered orally for each period
• Drug LY03017
  single dose，administered orally

Primary outcome measures

• 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]

Secondary outcome measures (1)

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [Time frame: Up to 96 hours after the last dose]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Mental Health Center — Shanghai

Identifiers

NCT: NCT06793995 · LY03017/CT-CHN-102

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗