A Drug-drug Interaction Study of SHR2150 on Healthy Chinese Volunteers

Human Immunodeficiency Virus Infection Clinical Trial

Official title:

A Single-centre, Single-arm, Open-label and Fixed-sequence Drug-drug Interaction Study to Evaluate the Effect of Efavirenz on the Pharmacokinetics of SHR2150 in Healthy Chinese Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05141422
• Other study ID #: SHR2150-I-105
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 13, 2021
• Est. completion date: January 22, 2022

Study information

• Verified date: December 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a single-centre, open-label, fixed-sequence, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects.

Subjects will take SHR2150 on Day 1 and Day 21, and take efavirenz from Day 7 to Day 26.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 22, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 the boundary value), male and female;

3. Male body weight = 50 kg, female body weight = 45 kg, body mass index (BMI) within the range of 18 ~ 26 kg/m2 (including the boundary value) (BMI= weight (kg)/height 2 (m2));

4. The physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound, and chest radiograph are normal or have no clinical significance;

5. The subjects with reproduction ability must agree to take effective contraceptive measures after signing the informed consent form and within 7 months (for female) or 4 months (for male) until the last 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 3 months before the trial, or plan to perform surgery during the study period;

3. Those whose 12-lead ECG is abnormal with clinically significant or ECG QT interval (QTcF) = 450 ms (for male) or > 460 ms (for female) or < 300 ms;

4. Those who donated blood or suffered heavy blood loss (=400 mL), received blood transfusions, or used blood products within 3 months before enrollment;

5. Have a history of allergies to drugs, food or other substances;

6. Those who have used soft drugs or hard drugs; or those with positive results in urine drug abuse screening;

7. Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration;

8. Those who have taken any medicine within 1 month 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;

9. Regular drinkers within 3 months before the test, that is, drinking more than 15 g of alcohol per day (15 g alcohol = 450 mL of beer, or 50 mL of spirits, or 150 mL of wine), and any alcohol-containing products cannot be stopped during the study;

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;

11. Women with pregnancy or within lactation period.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus Infection

Intervention

Drug:
• SHR2150 tablet?efavirenz
SHR2150 tablet single dose, Efavirenz single dose.

Locations

Country	Name	City	State
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tmax	Time to maximum observed serum concentration (Tmax) for SHR2150 after Single dose	from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
Primary	Cmax	Maximum observed serum concentration (Cmax) for SHR2150 after Single dose	from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
Primary	AUC0-t	Area under the plasma concentration versus time curve (AUC0-t) for SHR2150 after Single dose	from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
Primary	AUC0-inf	Area under the plasma concentration versus time curve (AUC0-inf ) for SHR2150 after Single dose	from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
Primary	T1/2	Time to elimination half-life (T1/2) for for SHR2150 after Single dose	from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose
Secondary	Number of subjects with adverse events and the severity of adverse events		from Day 1 to Day 37 after the first dose