A Drug-drug Interaction Study of SHR6390 on Healthy Chinese Volunteers

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: SHR6390、efavirenz

• Registration Number: NCT04973020
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-22
• Study Start: 2021-09-01
• Primary Completion: 2021-10-28
• Study Completion: 2021-10-28
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-25
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	SHR6390、efavirenz	-

Primary Outcome Measures

Name	Time	Method
Cmax	from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose	Maximum observed serum concentration (Cmax)for SHR6390 after Single dose.
AUC0-inf	from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose	Area under the plasma concentration versus time curve (AUC0-inf ) for SHR6390 after Single dose.
T1/2	from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose	Time to elimination half-life (T1/2) for for SHR6390 after Single dose.
Tmax	from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose	Time to maximum observed serum concentration (Tmax) for SHR6390 after Single dose.
AUC0-t	from Day 1 to Day 7 after the first dose and from Day 22 to Day 27 after the second dose	Area under the plasma concentration versus time curve (AUC0-t) for SHR6390 after Single dose.

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events and severity of adverse events	from Day 1 to Day 34 after the first dose

Trial Locations

Locations (1)

Xuanwu Hospital Beijing, Capital Medical University; 🇨🇳 Beijing, Beijing, China