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

Huntington Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05238701
• Other study ID #: LY03015/CT-CHN-101
• Status: Completed
• Phase: Phase 1
• Start date: February 25, 2022
• Est. completion date: November 4, 2023

Study information

• Verified date: January 2024
• Source: Luye Pharma Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 4, 2023
• Est. primary completion date: November 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Huntington Disease
• Tardive Dyskinesia

Intervention

Drug:
• LPM3770164 sustained release tablet
LPM3770164 sustained release tablet will be administrated orally single-dose on day 1
• LPM3770164 sustained release tablet simulant
LPM3770164 sustained release tablet simulant will be administrated orally single-dose on day 1

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Luye Pharma Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent adverse effects	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	Maximum observed concentration (Cmax)		from baseline to day 15
Secondary	Time to maximum observed concentration (Tmax)		from baseline to day 15
Secondary	Area under the concentration-time curve (AUC)		from baseline to day 15
Secondary	Clearance (CL)		from baseline to day 15
Secondary	Half-life (t1/2)		from baseline to day 15
Secondary	Mean Residence Time (MRT)		from baseline to day 15
Secondary	Haematology		baseline, day 3, day 8, day 15, day 28
Secondary	Blood Chemistry		baseline, day 3, day 8, day 15, day 28
Secondary	Urinalysis		baseline, day 15, day 28
Secondary	Coagulation		baseline, day 15, day 28
Secondary	Body Temperature		baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Secondary	Respiratory Rate		baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Secondary	Blood Pressure		baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Secondary	Pulse Rate		baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Secondary	Physical Examination		baseline, day 15, day 28
Secondary	12 lead electrocardiogram corrected QT interval		baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Secondary	Simpson-Angus Rating Scale (SAS)		baseline, day 3, day 28
Secondary	Barnes Akathisia Rating Scale (BARS)		baseline, day 3, day 28
Secondary	Abnormal Involuntary Movement Scale (AIMS)		baseline, day 3, day 28
Secondary	Stanford Sleepiness Scale (SSS)		baseline, day 3, day 28