Hepatic ImpairmentPhase 1NCT04631549
An Investigational Study of SHR3680 in Participants With Mild to Moderate Liver Impairment and Healthy Participants
A Phase 1 study testing SHR3680 in people with Hepatic Impairment and Healthy Participants, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to investigate SHR3680 in participants with different levels of liver function Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy Participants
- What is being tested?
- SHR3680
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2021to Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- 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;
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- 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.
Who cannot join
- -
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Eighth People'S Hospital
Guangzhou, Guangdong, 510060
Yujuan Guan, 020-83710403, gz8hgyj@126.com
About this study
Official title: 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
- Conditions
- Hepatic Impairment, Healthy Participants
- Being tested
- SHR3680
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR3680Drug
SHR3680, PO, single dose
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Experimental | Intervention: Drug: SHR3680 single dose Receives: Drug: SHR3680 |
| Mild liver impairment | Experimental | Intervention: Drug: SHR3680 single dose Receives: Drug: SHR3680 |
| Moderate liver impairment | Experimental | Intervention: Drug: SHR3680 single dose Receives: Drug: SHR3680 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration
Measured: Day1~Day29
AUC0-t
Area under the concentration time curve from time zero to time t
Measured: Day1~Day29
AUC0-∞
Area under the concentration time curve extrapolated to infinity
Measured: Day1~Day29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start3 Feb 2021
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631549
- Sponsor's protocol ID
- SHR3680-I-106
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2020
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Non-randomized, Open-label, Parallel Controlled Pharmacokinetic Study of SHR3680 in Participants With Mild to Moderate Liver Impairment and Healthy Participants
- ClinicalTrials.gov ID
- NCT04631549
- Acronym / sponsor ID
- SHR3680-I-106
- Conditions
- Hepatic Impairment, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate SHR3680 in participants with different levels of liver function
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Experimental | Drug: SHR3680Intervention: Drug: SHR3680 single dose |
| Mild liver impairment | Experimental | Drug: SHR3680Intervention: Drug: SHR3680 single dose |
| Moderate liver impairment | Experimental | Drug: SHR3680Intervention: Drug: SHR3680 single dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- -
- 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);
Key exclusion criteria (14 listed)
- -
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR3680SHR3680, PO, single dose | Drug | Healthy participants, Mild liver impairment, Moderate liver impairment |
Primary outcome
Cmax
Time frame: Day1~Day29
Maximum concentration
AUC0-t
Time frame: Day1~Day29
Area under the concentration time curve from time zero to time t
AUC0-∞
Time frame: Day1~Day29
Area under the concentration time curve extrapolated to infinity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR3680 in people with Hepatic Impairment and Healthy Participants, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day1~Day29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.