- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04631549
An Investigational Study of SHR3680 in Participants With Mild to Moderate Liver Impairment and Healthy Participants
November 30, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Multi-center, Non-randomized, Open-label, Parallel Controlled Pharmacokinetic Study of SHR3680 in Participants With Mild to Moderate Liver Impairment and Healthy Participants
The purpose of this study is to investigate SHR3680 in participants with different levels of liver function
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
GuangZhou, Guangdong, China, 510060
- Recruiting
- Guangzhou Eighth People's Hospital
-
Contact:
- Yujuan Guan
- Phone Number: 020-83710403
- Email: gz8hgyj@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
-
Participants with mild to moderate liver impairment must meet all of the following criteria to enter the study:
- The informed consent is signed before the trial, and the content, process and possible adverse reactions are fully understood; Be able to complete the study according to the requirements of the test scheme;
- Only for male, subjects aged 18 to 75 years (including both ends) on the date of signing informed consent;
- The body weight subjects is no less than 50 kg. Body mass index (BMI) is in the range of 19.0 kg/m2-29.0 kg/m2 (including the critical value);
- Primary liver disease (except for drug-induced liver injury) is necessary for patients with liver impairment, then patients with mild liver impairment (Child-Pugh score: 5-6) who are assessed as grade A according to Child-Pugh classification must be taken the clinical stability was ≥ 28 days before taking the experimental drug; while patients with moderate liver impairment (Child-Pugh score: 7-9) who are assessed as grade B according to Child-Pugh classification must be taken the clinical stability was ≥ 14 days before taking the experimental drug;
- Patients who have stable medication regimen for liver impairment, complications and other concomitant diseases within at least 28 days before taking the experimental drug, and the medication does not need to be adjusted (including drug type, dosage or frequency) during the clinical trials; or those who do not use the drug;
- The function of vital organs meets the following criteria: Absolute neutrophil count (ANC) ≥ 1.0 × 109 / L (1000 / mm3); Hemoglobin (Hgb) ≥ 9.0 g / dL (90g / L); Platelet ≥ 75.0 × 109 / L (75000 / mm3); Creatinine clearance rate (CLcr) ≥ 80 mL / min; The corrected QTc interval (QTcF) was less than 450 msec (male);
- In addition to liver impairment and complications, the investigator judged good condition according to the history inquiry, vital signs, physical examination, routine laboratory examination, 12-lead ECG, abdominal ultrasound scan, EEG, etc., and there was no other clinically significant abnormality;
- Male subjects are willing to have no family planning during the trial and within 6 months after the last administration of the trial drug, and voluntarily take effective contraceptive measures, or have undergone surgical sterilization.
Exclusion Criteria:
-
Participants with mild to moderate liver impairment who meet any of the following criteria will not be eligible for this study:
- Subjects had any of the following conditions: Patients with hepatic encephalopathy (according to Child-Pugh score); previous liver transplantation; severe portal hypertension or portal systemic shunt; suspected or diagnosed liver cancer or other malignant tumors; liver failure patients; esophageal and gastric variceal bleeding; severe / advanced ascites; hepatorenal syndrome patients; biliary tract Liver cirrhosis, biliary obstruction, cholestatic liver disease and other diseases that seriously affect bile excretion;
- In addition to the diseases leading to the diagnosis of liver impairment, the patients with severe acute and chronic diseases of other important organs within one year before screening, including but not limited to neuropsychiatric, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, were judged by the researchers to be unsuitable for the trial;
- Any of the following conditions occurred within 6 months prior to the study: myocardial infarction, congenital long QT syndrome, torsade de pointes (including persistent ventricular tachycardia and ventricular fibrillation), right bundle branch block and left anterior half block (bifascilar block), unstable angina pectoris, coronary / peripheral artery bypass grafting, and congestive heart failure syndrome (Grade III or IV according to NYHA), cerebrovascular accident, transient ischemic attack, or pulmonary embolism;
- Patients who had serious gastrointestinal diseases (except secondary gastrointestinal diseases caused by hepatitis) or had digestive system surgery 3 months before screening, and the researchers considered that drug absorption was affected;
- Warfarin or related coumarins were used for anticoagulant therapy within one month before screening, or warfarin or related coumarins were required for anticoagulant therapy during the trial period;
- During the screening period, liver function fluctuations (such as active hepatitis), rapid deterioration (such as advanced ascites, fever, active gastrointestinal bleeding), NCI CTCAE grade 2 or above, ongoing arrhythmia, and atrial fibrillation of any level occurred;
- People with allergic constitution, including those with severe drug allergy or history of drug allergy, and patients known to be allergic to the study drug SHR3680 or any excipients of the product;
- Those who have a history of drug use, or have a history of drug abuse in the past five years, or have a positive drug screening (except those with drug screening positive due to concomitant drug use);
- HIVAb positive, syphilisAb positive;
- Patients who have taken any clinical trial drugs within 3 months before screening; 14) Patients who had received drugs with definite potential hepatotoxicity and used them continuously for 7 days or more within 3 months before taking experimental drug;
- In 2 weeks before screening, they used traditional Chinese medicine (Chinese herbal medicine, Chinese patent medicine), dietary supplements and vitamins;
- Subjects with other factors not suitable to participate in this study were considered by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy participants
Intervention: Drug: SHR3680 single dose
|
SHR3680, PO, single dose
|
Experimental: Mild liver impairment
Intervention: Drug: SHR3680 single dose
|
SHR3680, PO, single dose
|
Experimental: Moderate liver impairment
Intervention: Drug: SHR3680 single dose
|
SHR3680, PO, single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: Day1~Day29
|
Maximum concentration
|
Day1~Day29
|
AUC0-t
Time Frame: Day1~Day29
|
Area under the concentration time curve from time zero to time t
|
Day1~Day29
|
AUC0-∞
Time Frame: Day1~Day29
|
Area under the concentration time curve extrapolated to infinity
|
Day1~Day29
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 3, 2021
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
July 1, 2023
Study Registration Dates
First Submitted
November 13, 2020
First Submitted That Met QC Criteria
November 15, 2020
First Posted (Actual)
November 17, 2020
Study Record Updates
Last Update Posted (Actual)
December 1, 2022
Last Update Submitted That Met QC Criteria
November 30, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- SHR3680-I-106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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