- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04305392
Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment
August 9, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment (Multicenter, Single Dose, Parallel, Open)
Study to evaluate pharmacokinetics, pharmacodynamics and safety of SHR4640 in patients with mild, moderate hepatic impairment and normal liver function in phase I clinical study.
Study Overview
Study Type
Interventional
Enrollment (Actual)
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
-
-
Beijing
-
Beijing, Beijing, China, 100069
- Meixia Wang
-
-
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 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
-
All subjects:
- Signing the informed consent forms.
- 18 years to 65 years (inclusive).
- Body mass index should be between 18 and 30 kg/m2 (inclusive).
- No medication was used before screening#or stable medication for 4 weeks.
Normal liver function:
• Clinical laboratory tests during the screening period were normal or the abnormality has no clinical significance.
Hepatic impaired subjects:
- Child-Pugh Classification score clinically determined as mild or moderate hepatic impairment.
- Liver damage due to primary liver disease.
Exclusion Criteria:
-
All subjects:
• Subject known or suspected of being sensitive to the study drugs or its ingredient.
Normal liver function:
- Previous history of liver function impairment, or physical examination and laboratory examination at screening indicated the presence or possibility of liver function impairment.
- Hepatitis B surface antigen (HBsAg) positive or Anti-hepatitis C virus (HCV) antibody or hepatitis C core antigen positive within 3 months prior to administration.
Hepatic impaired subjects:
- Suspected or diagnosed as liver cancer or with other malignant tumors.
- Drug induced liver injury#acute liver injury#liver transplantation history.
- Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.
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: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Normal liver function
Patients will receive single dose of SHR4640
|
orally SHR4640
|
EXPERIMENTAL: Mild Hepatic Impairment
Patients will receive single dose of SHR4640
|
orally SHR4640
|
EXPERIMENTAL: Moderate Hepatic Impairment
Patients will receive single dose of SHR4640
|
orally SHR4640
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Plasma Concentration (Cmax)
Time Frame: 72 hours after dosing
|
Peak Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
|
72 hours after dosing
|
Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞)
Time Frame: 72 hours after dosing
|
Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
|
72 hours after dosing
|
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)
August 4, 2020
Primary Completion (ANTICIPATED)
December 1, 2022
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
March 10, 2020
First Submitted That Met QC Criteria
March 10, 2020
First Posted (ACTUAL)
March 12, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR4640-105
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
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.
Clinical Trials on Hepatic Impairment
-
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-
GlycoMimetics IncorporatedCompletedModerate Hepatic Impairment | Normal Hepatic FunctionUnited States
-
Astellas Pharma Europe B.V.Medivation, Inc.CompletedSevere Hepatic Impairment | Normal Hepatic FunctionBulgaria
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Agios Pharmaceuticals, Inc.CompletedModerate Hepatic ImpairmentUnited States
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Merck Sharp & Dohme LLCCompletedModerate Hepatic ImpairmentUnited States
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EQRx International, Inc.CompletedSevere Hepatic ImpairmentUnited States
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PfizerCompleted
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TakedaCompletedSevere Hepatic ImpairmentUnited States
-
Bausch Health Americas, Inc.TerminatedSevere Hepatic ImpairmentUnited States
-
KBP BiosciencesCovanceCompletedHealthy | Moderate Hepatic ImpairmentUnited States
Clinical Trials on SHR4640
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Jiangsu HengRui Medicine Co., Ltd.Completed
-
Jiangsu HengRui Medicine Co., Ltd.Recruiting
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Jiangsu HengRui Medicine Co., Ltd.UnknownHyperuricemia | Primary Gout
-
Jiangsu HengRui Medicine Co., Ltd.CompletedHealthy Adult Male VolunteersChina
-
Jiangsu HengRui Medicine Co., Ltd.Completed
-
Atridia Pty Ltd.CompletedHyperuricemia | GoutAustralia
-
Jiangsu HengRui Medicine Co., Ltd.Unknown
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingPrimary Gout and Hyperuricemia