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Effect of Rifampicin on the Pharmacokinetics of SHR6390 in Healthy Subjects

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04439578
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
6.8
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the effect of rifampicin on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with rifampicin.

Condition or Disease Intervention/Treatment Phase
  • Drug: SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of SHR6390 in Healthy Chinese Adult Subjects.
Actual Study Start Date :
Jun 23, 2020
Actual Primary Completion Date :
Aug 17, 2020
Actual Study Completion Date :
Jan 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

subjects receiving a single oral dose of SHR6390 tablets, then rifampicin capsules 600 mg/day orally with a single oral dose of SHR6390 tablets co-administered.

Drug: SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin
600 mg rifampicin was administered in the morning.
Other Names:
  • rifampicin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics parameter: Cmax of SHR6390 [through study completion, an average of 32 days]

      Peak Plasma Concentration (Cmax) of SHR6390

    2. Pharmacokinetics parameter: AUC of SHR6390 [through study completion, an average of 32 days]

      Area under the plasma concentration versus time curve (AUC) of SHR6390

    Secondary Outcome Measures

    1. Pharmacokinetics parameter: Tmax of SHR6390 [:through study completion, an average of 32 days]

      Time of maximum observed concentration (Tmax) of SHR6390

    2. Pharmacokinetics parameter: T1/2 of SHR6390 [through study completion, an average of 32 days]

      Half time (T1/2) of SHR6390

    Eligibility Criteria

    Criteria

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

    1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;

    2. Ability to complete the study as required by the protocol;

    3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;

    4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);

    5. Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form to the date of the last medication. Serum HCG test of fertile women before the study must be negative

    6. Physical examination (vital signs, physical examination), routine laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram, orthotopic chest X-ray and abdominal B-ultrasound are normal or abnormal but have no clinical significance

    Exclusion Criteria:

    1. Allergic constitution;

    2. History of drug use, or drug abuse screening positive;

    3. Alcoholic or often drinkers;

    4. Left ventricular ejection fraction (LVEF) <50% by echocardiography;

    5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.

    6. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.

    7. Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening.

    8. Patients who have had any surgery and taken hepatotoxic drugs in the previous 6 months before screening.

    9. Patients who use any vitamin product or herb 14 days prior to screening.

    10. HCV positive, HIV antibody positive, HBsAg positive, syphilis antibody positive.

    11. Subjects who are considered unfit to participate in the study by the investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhejiang provincial people's hospital Hangzhou Zhejiang China 310014

    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:
    NCT04439578
    Other Study ID Numbers:
    • SHR6390-I-107
    First Posted:
    Jun 19, 2020
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 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:
    Rifampin

    Study Results

    No Results Posted as of Oct 18, 2021