Effect of Rifampicin on the Pharmacokinetics of SHR6390 in Healthy Subjects

NCT04439578 | Completed Phase 1

• 1 other identifier: SHR6390-I-107
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pharmacokinetics parameter: Tmax of SHR6390

  :through study completion, an average of 32 days

• Pharmacokinetics parameter: T1/2 of SHR6390

  through study completion, an average of 32 days

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin DRUG

600 mg rifampicin was administered in the morning.

Also known as: rifampicin

Treatment

Eligibility Criteria

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

You may qualify if:

• Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
• Ability to complete the study as required by the protocol;
• Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
• 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);
• 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
• 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

You may not qualify if:

• Allergic constitution;
• History of drug use, or drug abuse screening positive;
• Alcoholic or often drinkers;
• Left ventricular ejection fraction (LVEF) \<50% by echocardiography;
• 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.
• 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.
• Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening.
• Patients who have had any surgery and taken hepatotoxic drugs in the previous 6 months before screening.
• Patients who use any vitamin product or herb 14 days prior to screening.
• HCV positive, HIV antibody positive, HBsAg positive, syphilis antibody positive.
• Subjects who are considered unfit to participate in the study by the investigator

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhejiang provincial people's hospital

Hangzhou, Zhejiang, 310014, China

Location

MeSH Terms

Interventions

Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 19, 2020
• Study Start: June 23, 2020
• Primary Completion: August 17, 2020
• Study Completion: January 15, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

CN (1)