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

NCT06474650 | Completed Phase 1

• 1 other identifier: LY03015/CT-CHN-103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Huntington Disease; Tardive Dyskinesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (2)

Fed condition

EXPERIMENTAL

Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fed condition

Drug: LPM3770164 sustained release tablet

Fasted condition

EXPERIMENTAL

Period in which subjects receive a single oral dose of LPM3770164 sustained-release tablets in fasted condition

Drug: LPM3770164 sustained release tablet

Interventions

LPM3770164 sustained release tablet DRUG

Single-dose of 30 mg of LPM3770164 sustained release tablet

Also known as: LY03015

Fasted condition; Fed condition

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject who voluntarily participate and sign the informed consent form;
• Healthy male/female volunteers aged 18 to 45 years;
• 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;
• 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;
• 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;
• 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 a history of self-mutilation; or at risk of suicide;
• 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 has abnormal vital signs, laboratory abnormalities, and ECGs;
• Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing;
• 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 xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
• Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
• Subject who has participated in other clinical trials and were enrolled/randomized within 3 months before administration;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Conditions

Huntington Disease; Tardive Dyskinesia

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dyskinesia, Drug-Induced; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hufang Li, Doctor

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

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: June 20, 2024
• First Posted: June 25, 2024
• Study Start: July 31, 2024
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)