Esophageal cancer and other solid tumors
Conditions
Interventions
Group A:lerlotinib and rifampicin
Group B:lerlotinib and itraconazole
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions; 2. Able to complete the test according to the requirements of the test plan; 3. Subjects (including partners) voluntarily take effective contraceptive measures within 6 months after the last test drug administration; 4. Subjects aged 18-50 years (including 18 and 50 years old), no gender limit; 5. The weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg. Body mass index (BMI) = weight (kg)/height^2 (m^2), with a BMI in the range of 18-28 kg/m^2 (including critical values); 6. Physical examination, normal or abnormal vital signs have no clinical significance.
Exclusion criteria
Exclusion criteria: 1. Those who smoked more than 5 cigarettes per day on average within 3 months before the trial; 2. Allergic constitution (allergic to various drugs and food), allergic to lerlotinib or any drug component, allergic to the main active ingredients of rifampicin capsule and itraconazole capsule or any drug component; 3. History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 4. Those who have a history of drug abuse or have used drugs in the past five years; 5. Blood donation or massive blood loss (>450 mL) within 3 months before screening; 6. Those with dysphagia or suffering from gastrointestinal, liver and kidney diseases (whether cured or not) that can affect drug absorption or excretion within 6 months before screening; 7. Suffering from any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; 8. Taking any prescription drugs, over-the-counter drugs, any vitamin products or Chinese herbal medicines within 14 days prior to screening; 9. Taking any drugs that change the enzyme activity of liver drugs, such as barbiturates, rifampin, etc., within 30 days before screening; 10. Taking inhibitors or inducers of CYP3A4, CYP2C8, CYP2C19, and P-gp within 30 days before screening; 11. Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or exercised strenuously within 14 days before screening, or have other factors that affect drug absorption, distribution, metabolism, and excretion as judged by the researchers; 12. Those who participated in any drug clinical trial and used the experimental drug within 3 months before screening (if the subject withdraws from the study before administration, that is, does not receive administration, they can be enrolled in this study); 13. Abdominal color Doppler ultrasound, anteroposterior chest X-ray, and ECG are clinically significant, or the QT interval (QTcF) corrected by ECG during the screening period is >470 ms; 14. Female subjects are breastfeeding or have positive blood pregnancy results at screening and admission; 15. Abnormal clinical laboratory examinations have clinical significance, or other clinical findings within 12 months before screening show clinical significance of the following diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases); 16. Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen/antibody, and Treponema pallidum antibody; 17. Acute disease or concomitant medication occurred from the screening stage to the first administration of the test drug; 18. Consumed chocolate, any caffeine-containing or xanthine-rich food or drink within 24 hours before taking the test drug; 19. Those with a positive alcohol breath test; 20. Those who have been vaccinated within 28 days before screening, or who plan to be vaccinated during the trial; 21. The investigator believes that the subject is not suitable to participate in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the drug-time curve; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak concentration;Elimination half-life;Adverse event; | — |
Countries
China
Contacts
Public ContactJiang Yingzhi
Sunshine Lake Pharma Co.Ltd.
Outcome results
None listed