A Trial of DDI Between SHR1459 and Efavirenz With Healthy Subjects

NCT05560360 | Completed Phase 1

• 1 other identifier: SHR1459-I-110
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study used a single-dose, open and fixed sequence design to compare the pharmacokinetics in healthy subjects.

Conditions

B-cell Tumors

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics parameters of SHR1459: Cmax

  Based on pre-dose, 0-24 hours post-dose sampling times

• Pharmacokinetics parameters of SHR1459: AUC0-t

  Based on pre-dose, 0-24 hours post-dose sampling times

• Pharmacokinetics parameters of SHR1459: AUC0-inf

  Based on pre-dose, 0-24 hours post-dose sampling times

Secondary Outcomes (5)

• Pharmacokinetics parameters of SHR1459: Tmax

  Based on pre-dose, 0-24 hours post-dose sampling times

• Pharmacokinetics parameters of SHR1459: T1/2

  Based on pre-dose, 0-24 hours post-dose sampling times

• Pharmacokinetics parameters of SHR1459: CL/F

  Based on pre-dose, 0-24 hours post-dose sampling times

• Pharmacokinetics parameters of SHR1459: Vz/F

  Based on pre-dose, 0-24 hours post-dose sampling times

• Incidence and severity of adverse events/serious adverse events (base on CTC AE 5.0)

  Based on pre-dose to Day 24

Study Arms (1)

healthy subjects

EXPERIMENTAL

Drug: SHR1459 tablet; Drug: Efavirenz tablet

Interventions

SHR1459 tablet DRUG

100 mg/tablet; administered orally

healthy subjects

Efavirenz tablet DRUG

600 mg/tablet; administered orally

healthy subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed the informed consent before the test, and fully understood the test content, process and possible adverse reactions;
• Age 18-45 (including threshold), male and female(at least 5 female subjects);
• Weight ≥ 50 kg for male, weight ≥ 45 kg for female, body mass index (BMI): 18.5\~30 kg/m2 (including critical value);
• Heart rate 60-100 bpm;
• Be able to communicate well with the investigators and understand and comply with the requirements in this study.

You may not qualify if:

• Physical examination, vital signs, blood-routine examination, blood biochemistry, infectious disease screening, coagulation function, urine-routine examination, chest x-ray, B ultrasound and other examination results are abnormal and judged by the research doctor as clinically significant;
• Glomerular filtration rate (GFR) \< 90 mL/min/1.73 m2;
• lead ECG abnormalities, in which QTcF≥ 430 ms for men and QTcF≥ 450 ms for women, (the QTc interval is corrected by the Fridericia formula (QTcF = QT/(RR\^0.33), RR is the standardized heart rate value, divided by heart rate of 60), sinus arrhythmias, sinus bradycardia, or other abnormalities are judged to be clinically significant by research physicians;
• Those who have previously suffered from severe heart, lung, liver, kidney, blood, gastrointestinal, endocrine, immune, skin, neurological or psychiatric diseases or existing above diseases, which are judged by the research doctor to be unfit for participants;
• Those who have undergone any surgery within 6 months prior to screening; or have previously undergone any surgery that affects the absorption of the drug in the stomach and intestines (including gastrectomy, bowel resection, gastric contraction surgery, etc.) and any surgery that affects liver function (including cholecystectomy, etc.);
• Screening for any acute illness that has occurred within the month prior to the study as clinically significant;
• Those with a specific history of allergies (e.g., asthma, urticaria, eczema, etc.), or have allergic constitution (those who are allergic to two or more drugs, foods, or environmental substances such as alcohol, milk, pollen, etc.), or those with a known history of allergies to SHR1459, efavirenz, or their excipients (SHR1459, see Appendix 2 for efavirenz excipients);
• Have used any drugs that effect enzyme activity (e.g., antivirals, antifungals, antiplatelet aggregations, etc.) in the month prior to taking the study drug;
• Have any prescription drugs, nonprescription drugs, vitamins, health supplements, proprietary Chinese medicines and herbs within month before taking the research drugs;
• Persons with history of drug abuse/dependence in the past five years; Those with history of drug abuse or positive drug screening (including morphine, methamphetamine( methamphetamine), ketamine, ecstasy (methylenedioxyamphetamine), cocaine, cannabis (tetrahydrocannabinol acid) positive);
• Alcohol abuse in the 3 months prior to screening, with an average daily intake of more than 15g of alcohol (equivalent to 145 mL of wine, 450 mL of beer or 43 mL of liquor with an alcohol content of 40%), and those who cannot abstain from alcohol during the trial, or those who have a positive alcohol breath screening;
• Those who smoke more 5 cigarettes per day in the 3 months before screening or those who do not agree to quit smoking during the test, or those who are positive for urine nicotinic screen;
• Those who donate blood or other reasons of bleeding cause the total loss of blood more than 200mL or receive blood transfusions within 3 months before screening;
• Those who have used other experimental drugs or medical devices within 3 months before screening or who have used experimental biological macromolecules within 1 year;
• From 48 hours before taking the study drug to the end of the study, subjects have xanthine-rich beverages (chocolate, coffee, tea, etc.) or food (animal liver, etc.), or grapefruit, star fruit and other fruits or juices that may affect metabolism;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, 222002, China

Location

MeSH Terms

Interventions

efavirenz

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Compare the pharmacokinetic effects of efavirenz on SHR1459 in healthy subjects.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 29, 2022
• Study Start: November 4, 2022
• Primary Completion: December 2, 2022
• Study Completion: January 27, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-02

Locations

CN (1)