Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets

A Randomized, Open-label, Two-period, Double-crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets in Healthy Subjects

This is a A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164 sustained-release tablets 30 mg in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Tardive Dyskinesia; Huntington Disease
• Intervention / Treatment: Drug: LPM3770164 sustained release tablet

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subject who voluntarily participate and sign the informed consent form;
2. Healthy male/female volunteers aged 18 to 45 years;
3. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 ~ 26.0 kg/m2, inclusive;
4. Able to comply with the lifestyle restrictions.

Exclusion Criteria:

1. Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
2. Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results;
3. 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;.
4. Subject has a history of self-mutilation; or at risk of suicide;
5. 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;
6. Subject has abnormal vital signs, laboratory abnormalities, and ECGs;
7. Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing;
8. Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust);
9. Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results;
10. Subject has a history of substance abuse within 1 year or a positive urine drug screen;
11. Subject who has daily smoking of ≥ 5 cigarettes within 3 months;
12. Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia
13. Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
14. Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
15. Subject who has participated in other clinical trials and were enrolled/randomized within 3 months before administration;
16. Subject has used blood products or being blood donor or blood loss within 3 months;
17. Pregnant, lactating women, or positive pregnancy test;
18. Subject who refusal to contraception, or plan to donate sperm or ovums;
19. Other conditions which would make participation in the study unsuitable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fed condition; Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fed condition	Drug: LPM3770164 sustained release tablet; Single-dose of 30 mg of LPM3770164 sustained release tablet; Other Names: LY03015
Experimental: Fasted condition; Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fasted condition	Drug: LPM3770164 sustained release tablet; Single-dose of 30 mg of LPM3770164 sustained release tablet; Other Names: LY03015

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak Plasma Concentration (Cmax)	Predose and up to 240 hours postdose
Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)	Predose and up to 240 hours postdose
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf)	Predose and up to 240 hours postdose

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment-emergent adverse event	from baseline to day 25
Time to maximum concentration (Tmax)	Predose and up to 240 hours postdose
Half-life (t1/2)	Predose and up to 240 hours postdose

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.
• Investigators: Principal Investigator: Hufang Li, Doctor, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Actual): September 25, 2024
• Study Completion (Actual): September 25, 2024

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Neurocognitive Disorders; Cognition Disorders; Dementia; Neurodegenerative Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Basal Ganglia Diseases; Dyskinesia, Drug-Induced; Chorea; Tardive Dyskinesia; Dyskinesias; Huntington Disease
• Other Study ID Numbers: LY03015/CT-CHN-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No