Effect of Rifampicin on the Pharmacokinetics of SHR6390 in Healthy Subjects

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital

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. 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

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameter: Cmax of SHR6390	Peak Plasma Concentration (Cmax) of SHR6390	through study completion, an average of 32 days
Pharmacokinetics parameter: AUC of SHR6390	Area under the plasma concentration versus time curve (AUC) of SHR6390	through study completion, an average of 32 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics parameter: T1/2 of SHR6390	Half time (T1/2) of SHR6390	through study completion, an average of 32 days
Pharmacokinetics parameter: Tmax of SHR6390	Time of maximum observed concentration (Tmax) of SHR6390	:through study completion, an average of 32 days

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): August 17, 2020
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin
• Other Study ID Numbers: SHR6390-I-107

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