Hepatic ImpairmentPhase 1NCT04305392
Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment
A Phase 1 study testing SHR4640 in people with Hepatic Impairment, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- SHR4640
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2020to Dec 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- 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.
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- 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.
Who cannot join
- -
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hepatic Impairment
- Being tested
- SHR4640
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4640Drug
orally SHR4640
| Study group | Role | What they receive |
|---|---|---|
| Normal liver function | Experimental | Patients will receive single dose of SHR4640 Receives: Drug: SHR4640 |
| Mild Hepatic Impairment | Experimental | Patients will receive single dose of SHR4640 Receives: Drug: SHR4640 |
| Moderate Hepatic Impairment | Experimental | Patients will receive single dose of SHR4640 Receives: Drug: SHR4640 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
Measured: 72 hours after dosing
Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞)
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
Measured: 72 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start4 Aug 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
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
- NCT04305392
- Sponsor's protocol ID
- SHR4640-105
- Status last verified
- Aug 2022
- First submitted
- 10 Mar 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment (Multicenter, Single Dose, Parallel, Open)
- ClinicalTrials.gov ID
- NCT04305392
- Acronym / sponsor ID
- SHR4640-105
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Mar 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal liver function | Experimental | Drug: SHR4640Patients will receive single dose of SHR4640 |
| Mild Hepatic Impairment | Experimental | Drug: SHR4640Patients will receive single dose of SHR4640 |
| Moderate Hepatic Impairment | Experimental | Drug: SHR4640Patients will receive single dose of SHR4640 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- -
- 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.
Key exclusion criteria (10 listed)
- -
- Subject known or suspected of being sensitive to the study drugs or its ingredient.
- 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.
- Suspected or diagnosed as liver cancer or with other malignant tumors.
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 |
|---|---|---|
| SHR4640orally SHR4640 | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, Normal liver function |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SHR4640 in people with Hepatic Impairment, 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 11 inclusion and 10 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 10 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 72 hours after dosing). The study lists 2 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 10 Aug 2022.