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CompletedNCT06474650Updated Dec 12, 2024

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

A Phase 1 interventional study of LPM3770164 sustained release tablet in Huntington Disease and Tardive Dyskinesia, 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
16
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

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Conditions studied

  • Huntington Disease
  • Tardive Dyskinesia
03

In context

Dyskinesias

270 studies on the registry are indexed under Dyskinesias; 41 are open to participants now.

This study's enrollment of 16 is below the median of 44 across 192 interventional studies indexed under Dyskinesias.

Browse Dyskinesias studies →

Lead sponsor

Luye Pharma Group Ltd. is the lead sponsor of 72 studies on the registry; 15 are open to participants now.

Of its 13 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

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 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugLPM3770164 sustained release tablet

    Single-dose of 30 mg of LPM3770164 sustained release tablet

    Also known as: LY03015

06

What researchers measure

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: Predose and up to 240 hours postdose

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

    Time frame: Predose and up to 240 hours postdose

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

    Time frame: Predose and up to 240 hours postdose

Secondary outcomes

  1. Treatment-emergent adverse event

    Time frame: from baseline to day 25

  2. Time to maximum concentration (Tmax)

    Time frame: Predose and up to 240 hours postdose

  3. Half-life (t1/2)

    Time frame: Predose and up to 240 hours postdose

07

Study locations

1 site
  • Shanghai Mental Health Center
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
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 ↗
10

Registry details

Key details

Study ID
NCT06474650
Lead sponsor
Luye Pharma Group Ltd.
Responsible party
Sponsor
First posted
Jun 25, 2024
Start date
Jul 31, 2024
Primary completion
Sep 25, 2024
Completion
Sep 25, 2024
Last update
Dec 12, 2024

Study contacts

Hufang Li, Doctor
principal investigator · Shanghai Mental Health Center

Oversight

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

Not currently enrolling

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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