A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Characteristics of Multiple Doses of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia

Luye Pharma Group Ltd.1 site in 1 country120 target enrollmentJanuary 14, 2025

InterventionsLPM3770164 sustained release tablet 5 mg LPM3770164 sustained release tablet 10 mg LPM3770164 sustained release tablet 20 mg LPM3770164 sustained release tablet simulant

DrugsLPM3770164 sustained release tablet 5 mg LPM3770164 sustained release tablet 10 mg LPM3770164 sustained release tablet 20 mg LPM3770164 sustained release tablet simulant

Overview

Phase: Phase 1
Intervention: LPM3770164 sustained release tablet 5 mg
Conditions: Tardive Dyskinesia (TD)
Sponsor: Luye Pharma Group Ltd.
Enrollment: 120
Locations: 1
Primary Endpoint: Treatment-emergent adverse event
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled parallel-group trial to evaluate the safety, tolerability, preliminary efficacy and PK characteristics of multiple doses of LPM3770164 sustained-release tablets in TD patients.

Registry

clinicaltrials.gov

Start Date

January 14, 2025

End Date

October 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Luye Pharma Group Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject who voluntarily participate in and sign the informed consent form;
•Male or female subjects aged ≥ 18 years and \< 65 years;
•Body mass index (BMI) 18.5 \~ 38.0 kg/m2 (including boundary value);
•Subjects with a past diagnosis of schizophrenia, schizoaffective disorder, bipolar and related disorders, depressive disorders based on medical history, and stable for at least 1 month;
•Subjects who have been diagnosed with medication-induced TD, and whose symptoms have lasted for at least 3 months according to the DSM-5; and TD is assessed as moderate or severe (AIMS Item 8 score ≥3);
•Medications for schizophrenia, schizoaffective disorder, bipolar and related disorders, depressive disorders and extrapyramidal reactions should be kept dose stable for at least 1 month (benzodiazepines should stable at least 14 days, Long-acting injection should stable for at least 3 months);
•Females of childbearing potential have a negative pregnancy test. Male and female patients of childbearing potential and their spouses/partners agree to not plan to become pregnant (including the plan for sperm and egg donation) and to use effective contraceptive measures throughout the study and for at least 1 month after the last dose of the study drug.

Exclusion Criteria

•Has comorbid abnormal involuntary movement(s) that is more prominent than TD as judged by the investigator;
•Has Simpson-Angus Scale (SAS) score≥ 3 on two or more items other than items 8 and 10;
•Currently in the acute phase of mental disorder or severe psychiatric symptoms, unable to cooperate with the treatment and assessment, as judged by the investigator;
•Has a history of suicide attempt or Question 4 or Question 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) as "Yes" within the past 6 months;
•Has a history of neuroleptic-related malignant syndrome;
•Has diagnosed with malignant tumor within 3 years before randomization;
•Has a history of long QT syndrome or tachyarrhythmia within 3 years before randomization;
•Electrocardiogram QTcF \> 450 ms, or other clinically significant ECG findings in the opinion of the investigator;
•Patients with significant abnormal liver and kidney function indicators, meeting any of the following criteria: serum creatinine \> 1.5 × upper limit of normal (ULN); serum alanine transaminase (ALT) or aspartate transaminase (AST) \> 2.5 × ULN; total bilirubin \> 1.5 × ULN;
•Has active, severe and unstable cerebrovascular, liver, kidney, endocrine, cardiovascular, gastrointestinal, respiratory, or metabolic disorders within 30 days prior to screening, in the judgment of the investigator, would interfere with the patient's ability to participate in the trial;

Arms & Interventions

LPM3770164 sustained release tablet 5 mg

Intervention: LPM3770164 sustained release tablet 5 mg

LPM3770164 sustained release tablet 10 mg

Intervention: LPM3770164 sustained release tablet 10 mg

LPM3770164 sustained release tablet 20 mg

Intervention: LPM3770164 sustained release tablet 20 mg

Placebo

Intervention: LPM3770164 sustained release tablet simulant

Outcomes

Primary Outcomes

Treatment-emergent adverse event

Time Frame: From baseline to Week 8

Number of participants with treatment-emergent adverse event will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.

Change in Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score

Time Frame: From baseline to Week 8

Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.

Secondary Outcomes

The proportion of subjects who have a 50% improvement in AIMS Dyskinesia Total Score(From baseline to Week 8)
Clinical Global Impression - Global Improvement of TD (CGI-TD)(From Week 2 to Week 8)
Patient Global Impression of Change (PGIC)(From Week 2 to Week 8)
Maximum observed concentration (Cmax)(From predose to 24 hours of day 1)
Area Under the Curve from time 0 to 24 hours of day 1 (AUC0-24h)(From predose to 24 hours of day 1)
Concentration at the end of the dosing interval at steady state (Cτ,ss)(Predose on Day 14±2, Day 28±2 and Day 42±2)