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CompletedNCT06216054Updated Dec 12, 2024

Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 in Healthy Subjects

A Phase 1 interventional study of LPM3770164 sustained release tablet and LPM3770164 sustained release tablet simulant in Tardive Dyskinesia and Huntington Disease, sponsored by Luye Pharma Group Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Luye Pharma Group Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending doses 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 later clinical trials.

02

Conditions studied

  • Tardive Dyskinesia
  • Huntington Disease
03

In context

Tardive Dyskinesia

59 studies on the registry are indexed under Tardive Dyskinesia; 9 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 49 interventional studies indexed under Tardive Dyskinesia.

Browse Tardive Dyskinesia studies →

Lead sponsor

Luye Pharma Group Ltd. is the lead sponsor of 74 studies on the registry; 15 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    LPM3770164

    LPM3770164 sustained-release tablets will be administrated with multiple doses from 5mg to 30mg on day 1\~10

    Drug: LPM3770164 sustained release tablet

  • Placebo comparator
    Placebo

    LPM3770164 sustained release tablet simulant will be administrated on day 1\~10

    Drug: LPM3770164 sustained release tablet simulant

Interventions

06

What researchers measure

Primary outcomes

  1. Treatment-emergent adverse event

    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.

    Time frame: from baseline to day 37

Secondary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: from day 1 to day 24

  2. Area Under the Curve from time 0 to 24 hours (AUC0-24)

    Time frame: from day 1 to day 24

  3. Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)

    Time frame: from day 1 to day 24

  4. Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf)

    Time frame: from day 1 to day 24

  5. Time to maximum concentration (Tmax)

    Time frame: from day 1 to day 24

  6. Half-life (t1/2)

    Time frame: from day 1 to day 24

  7. ECG QTc Interval

    Time frame: from baseline to day 37

07

Study locations

1 site
  • Shanghai Mental Health Center
    Shanghai, Shanghai Municipality, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2023 to primary completion in Jul 2024, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2023
First posted
Jan 22, 2024
StartActual
Dec 19, 2023
Primary completionActual
Jul 29, 2024
CompletionActual
Jul 29, 2024
Last update
Dec 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06216054
Responsible party
Sponsor
First posted
Jan 22, 2024
Start date
Dec 19, 2023
Primary completion
Jul 29, 2024
Completion
Jul 29, 2024
Last update
Dec 12, 2024

Study contacts

Huafang Li, Doctor
principal investigator · Shanghai Mental Health Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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