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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05141422
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
1.3
Anticipated Duration (Months)
15.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SHR2150 tablet、efavirenz
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The study is a single-centre, single-arm, open-label and fixed-sequence clinical trial.The study is a single-centre, single-arm, open-label and fixed-sequence clinical trial.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Dec 13, 2021
Anticipated Primary Completion Date :
Jan 15, 2022
Anticipated Study Completion Date :
Jan 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

SHR2150+ efavirenz

Drug: SHR2150 tablet、efavirenz
SHR2150 tablet single dose, Efavirenz single dose.

Outcome Measures

Primary Outcome Measures

  1. Tmax [from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose]

    Time to maximum observed serum concentration (Tmax) for SHR2150 after Single dose

  2. Cmax [from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose]

    Maximum observed serum concentration (Cmax) for SHR2150 after Single dose

  3. AUC0-t [from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose]

    Area under the plasma concentration versus time curve (AUC0-t) for SHR2150 after Single dose

  4. AUC0-inf [from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose]

    Area under the plasma concentration versus time curve (AUC0-inf ) for SHR2150 after Single dose

  5. T1/2 [from Day 1 to Day 7 after the first dose and from Day 21 to Day 27 after the second dose]

    Time to elimination half-life (T1/2) for for SHR2150 after Single dose

Secondary Outcome Measures

  1. Number of subjects with adverse events and the severity of adverse events [from Day 1 to Day 37 after the first dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The People's Hospital of Liaoning Province Shenyang Liaoning China 110067

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05141422
Other Study ID Numbers:
  • SHR2150-I-105
First Posted:
Dec 2, 2021
Last Update Posted:
Dec 20, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Efavirenz

Study Results

No Results Posted as of Dec 20, 2021