Clinical trial NCT04973020: A Drug-drug Interaction Study of SHR6390 on Healthy Chinese Volunteers
Official title: A Single-centre, Single-dose, Open-label and Self-control Study to Evaluate the Effect of Efavirenz on Pharmacokinetic of SHR6390 in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a single-center, open, single-dose, self-controlled clinical trial.
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a single-center, open, single-dose, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects.Subjects will take the SHR6390 on Day1 and Day22 , and from Day8 to Day26 take the efavirenz.


Eligibility criteria: Inclusion Criteria:

1. The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent;
2. Healthy subjects aged 18\~45 (including 18 and 45 years old);
3. Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 \~ 26kg /m2 (including 19 and 26 kg/m2) (BMI= weight (kg)/height 2 (m2));
4. The subjects had no fertility plan, took effective contraceptive measures voluntarily, and could not donate sperm or eggs within 7 months after signing the informed consent form to the last medication; the serum HCG test of women with fertility must be negative before the study medication.

Exclusion Criteria:

1. Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results.
2. Those who have undergone surgery within 6 months before the trial, or plan to perform surgery during the study period;
3. Those who donated blood or suffered heavy blood loss (≥400 mL), received blood transfusions, or used blood products within 3 months before enrollment;
4. Have a history of allergies to drugs, food or other substances;
5. Those who have used soft drugs (such as marijuana) within 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the test; Those with positive results in urine drug abuse screening;
6. Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration;
7. Those who have taken any medicine within 4 weeks before the first administration (including prescription medicines, non-prescription medicines, Chinese herbal medicines, vitamins, calcium tablets and other food supplements), especially the drugs which have any effect on CYP3A4;
8. Regular drinkers within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine), and any alcohol-containing products cannot be stopped during the study Those who are positive for alcohol breath test;
9. Those with any abnormal result (clinically significant) of vital signs, physical examination, 12-lead electrocardiogram, chest radiograph, abdominal ultrasound, colour Doppler echocardiography, hematology, clinical chemistry, urinalysis and coagulation;
10. Hepatitis B virus surface antigen is positive, or hepatitis C virus antibody is positive, or treponema pallidum antibody is positive, or human immunodeficiency virus antibody is positive.

Primary outcomes:
measure: Tmax
timeFrame: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
measure: Cmax
timeFrame: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
measure: AUC0-t
timeFrame: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
measure: AUC0-inf
timeFrame: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
measure: T1/2
timeFrame: from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose
Secondary outcomes:
measure: Number of subjects with adverse events and severity of adverse events
timeFrame: from Day 1 to Day 34 after the first dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Beijing, Capital Medical University
state: Beijing
Study officials:
References: