A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy Subjects

January 26, 2024 updated by: Luye Pharma Group Ltd.

A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 Sustained-release Tablets in Healthy Subjects

This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for subsequent clinical trials.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (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 ~ 28.0 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, 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 14 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 or a positive urine drug screen;
  11. Subject who has daily smoking of ≥ 5 cigarettes;
  12. Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
  13. Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
  14. Subject who has participated in other clinical trials within 3 months before administration;
  15. Subject has used blood products or being blood donor or blood loss;
  16. Pregnant, lactating women, or positive pregnancy test;
  17. Subject who refusal to contraception, or plan to donate sperm or ovums;
  18. Other conditions which would make participation in the study unsuitable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LPM3770164
LPM3770164 sustained-release tablets will be administrated with single dose from 0.5mg to 60mg
Drug: LPM3770164 sustained release tablet
LPM3770164 sustained release tablet will be administrated orally single-dose on day 1
Other Names:
  • LY03015
Placebo Comparator: Placebo
LPM3770164 sustained release tablet simulant will be administrated with single dose
Drug: LPM3770164 sustained release tablet simulant
LPM3770164 sustained release tablet simulant will be administrated orally single-dose on day 1
Other Names:
  • LY03015 simulant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment-emergent adverse effects
Time Frame: from baseline to day 28
Number of participants with treatment-emergent adverse effects will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.
from baseline to day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: from baseline to day 15
from baseline to day 15
Time to maximum observed concentration (Tmax)
Time Frame: from baseline to day 15
from baseline to day 15
Area under the concentration-time curve (AUC)
Time Frame: from baseline to day 15
from baseline to day 15
Clearance (CL)
Time Frame: from baseline to day 15
from baseline to day 15
Half-life (t1/2)
Time Frame: from baseline to day 15
from baseline to day 15
Mean Residence Time (MRT)
Time Frame: from baseline to day 15
from baseline to day 15
Haematology
Time Frame: baseline, day 3, day 8, day 15, day 28
baseline, day 3, day 8, day 15, day 28
Blood Chemistry
Time Frame: baseline, day 3, day 8, day 15, day 28
baseline, day 3, day 8, day 15, day 28
Urinalysis
Time Frame: baseline, day 15, day 28
baseline, day 15, day 28
Coagulation
Time Frame: baseline, day 15, day 28
baseline, day 15, day 28
Body Temperature
Time Frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Respiratory Rate
Time Frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Blood Pressure
Time Frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Pulse Rate
Time Frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Physical Examination
Time Frame: baseline, day 15, day 28
baseline, day 15, day 28
12 lead electrocardiogram corrected QT interval
Time Frame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Simpson-Angus Rating Scale (SAS)
Time Frame: baseline, day 3, day 28
baseline, day 3, day 28
Barnes Akathisia Rating Scale (BARS)
Time Frame: baseline, day 3, day 28
baseline, day 3, day 28
Abnormal Involuntary Movement Scale (AIMS)
Time Frame: baseline, day 3, day 28
baseline, day 3, day 28
Stanford Sleepiness Scale (SSS)
Time Frame: baseline, day 3, day 28
baseline, day 3, day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Luye Pharma Group Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hufang Li, Doctor, Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LY03015/CT-CHN-101

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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