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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Human Immunodeficiency Virus Infection
• Intervention / Treatment: Drug: SHR2150 tablet、efavirenz

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110067
      • The People's Hospital of Liaoning Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; SHR2150+ efavirenz	Drug: SHR2150 tablet、efavirenz; SHR2150 tablet single dose, Efavirenz single dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events and the severity of adverse events	from Day 1 to Day 37 after the first dose

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Anticipated): January 15, 2022
• Study Completion (Anticipated): January 22, 2022

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Efavirenz
• Other Study ID Numbers: SHR2150-I-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No