Huntington Disease
Conditions
Brief summary
This is a phase 1, single-center, single-dose, open-label mass-balance study to evaluate radioactive recovery rate, radioactive PK characteristics, metabolite identification, and to observe the safety in healthy male subjects of \[14C\] LPM3770164.
Interventions
DRUG[14C] LPM3770164
The subjects are required to take 20 mg/150 µCi \[14C\] LPM3770164 tablet (s) in the fasted state with a total of approximately 240 mL of water to ensure completion within 5 minutes
Sponsors
Luye Pharma Group Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult Chinese males; 2. Age at informed consent: 18-45 years (including boundary value); 3. Body mass index (BMI) range of 19-26 kg/m2 (including the boundary value), and body weight of not less than 50 kg; 4. There is no plan to have children or donate sperm within 1 year after the participant signs the informed consent form and the participant voluntarily takes strict contraceptive measures within 1 year after signing the informed consent form and completing the trial; 5. Fully understand the purpose and requirements of this study, and voluntarily sign the informed consent form; 6. Able to communicate well with the investigators and be able to complete the trial according to the protocol.
Exclusion criteria
1. Abnormal and clinically significant vital signs, physical examination, chest X-ray (anteroposterior), ophthalmic examination, anal digital examination and abdominal B ultrasound examination; 2. Abnormal laboratory examination during the screening period, and clinically significant according to the investigator's judgment: 3. QTcF interval \> 450 ms in men; or other abnormalities are clinically significant in the judgment of the investigator; 4. Abnormal tests of hepatitis B surface antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), treponema pallidum antibody and human immunodeficiency virus antibody are clinically significant at the investigator's discretion; 5. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicine, food supplements within 4 weeks prior to screening; 6. Use of any drugs that inhibit or induce hepatic drug metabolizing enzyme activity within 4 weeks prior to screening; 7. History of any clinically significant disease or disease or condition that may affect the results of the trial; 8. History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, tachycardia, atrioventricular block, QT prolongation syndrome or a family history of QT prolongation syndrome symptoms; 9. . Patients with dysphagia, esophageal stenosis or gastrointestinal diseases that cause clinically significant symptoms or with a history of severe vomiting and diarrhea in the week prior screening; 10. Patients who previously underwent surgery that would affect the absorption, distribution, metabolism and excretion of drugs, or had undergone major surgery or had incomplete healing of surgical incision within 6 months prior to the screening period; or planned to undergo surgery during the study period; 11. History of drug, food, or environmental allergy, especially to components similar to the investigational product, or a known allergic constitution; 12. Patients with symptomatic hemorrhoids or diseases accompanied by regular/ongoing hematochezia, irritable bowel syndrome, and inflammatory bowel disease; 13. History of congenital or acquired urinary tract stenosis, prostatic hyperplasia, or abnormal bladder function; 14. Habitual diarrhea or average bowel movement frequency less than once daily; 15. Alcoholics or regular drinkers within 6 months before screening, that is, drinking more than 14 units of alcohol per week, or alcohol breath test results \> 0 mg/100ml at screening, or drinkers within 48 hours before the use of the test drug, or unable to abstain from alcohol during the test; 16. The average daily smoking amount in the 3 months before screening is greater than 5 cigarettes or habitual use of nicotine-containing products, or unable to abstain during the trial; 17. Previous history of drug abuse or drug abuse, or positive urine drug abuse screening; 18. Excessive consumption of tea, coffee and/or caffeine-rich beverages, grapefruit juice and other beverages that affect liver enzyme activity per day within 3 months before screening, or inability to abstain during the trial; 19. Those with special requirements for diet or failing to comply with the unified diet; 20. Those who plan to have strenuous exercise during the trial; 21. Workers engaged in long-term exposure to radioactive conditions, or those with significant radioactive exposure; 22. Blood loss or blood donation; 23. Those with a history of fainting, blood, or difficult to collect blood or unable to tolerate venipuncture blood collection; 24. Those who have participated in any clinical trial within 3 months prior to screening and have received investigational drugs or used investigational devices; or those who plan to participate in other clinical trials during this study; 25. Those who have received vaccination within 4 weeks prior to screening or plan to receive vaccination during the trial to 1 month after the end of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery of total radioactivity in excreta (urine and feces) per collection period; | within up to 40 days after dosing |
| Cumulative recovery of total radioactivity in excreta (urine and feces) | within up to 40 days after dosing |
| Percentage of parent drug and its metabolites in plasma to total radioactivity exposure (% AUC) in human plasma | within up to 40 days after dosing |
| Percentage of parent drug and its metabolites in urine and feces to administered dose (% administered dose) | within up to 40 days after dosing |
| Identification of major metabolites in human plasma, urine and feces | within up to 40 days after dosing |
| Peak concentration (Cmax) of total radioactivity in human plasma | within up to 40 days after dosing |
| Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf) of total radioactivity in human plasma. | within up to 40 days after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse event | From baseline to 40 days after doing |
Countries
China
Contacts
CONTACTyiqing Zhao, Doctor
Outcome results
None listed