Hepatic ImpairmentPhase 1NCT03160014
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment
A Phase 1 study testing SHR3824 in people with Hepatic Impairment, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- SHR3824
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Dec 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years to 75 years (inclusive)
- Body mass index should be between 18 and 33 kg/m2 (inclusive) (ie, a measure of one's weight in relation to height)
- Liver damage due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis of the liver (except for patients with drug-induced liver injury)
Who cannot join
- allergic to SGLT2 inhibitor analogues or any other similar structure;
- lactose intolerance history or lactose intolerance;
- Suspected or diagnosed as liver cancer or with other malignant tumors;
- Alcoholic liver, autoimmune liver disease, liver transplantation history
Trial locations and contacts
1 site in 1 country.
XinMin Zhou contact
About this study
Official title: Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment (Single-Center, Open-label, Parallel-Group, Single-Dose Study)
Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.
- Conditions
- Hepatic Impairment
- Being tested
- SHR3824
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR3824Drug
Drug: SHR3824 20mg/day, oral tablet, single dose
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Drug: SHR3824 20mg/day, oral tablet, single dose Receives: Drug: SHR3824 |
| Mild Hepatic Impairment | Experimental | Drug: SHR3824 20mg/day, oral tablet, single dose Receives: Drug: SHR3824 |
| Moderate Hepatic Impairment | Experimental | Drug: SHR3824 20mg/day, oral tablet, single dose Receives: Drug: SHR3824 |
| Severe Hepatic Impairment | Experimental | Drug: SHR3824 20mg/day, oral tablet, single dose Receives: Drug: SHR3824 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration-time curve (AUC) of SHR3824
AUC (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients
Measured: 72 hours after dosing
The maximum plasma concentration (Cmax) of SHR3824
Cmax (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients.
Measured: 72 hours after dosing
Secondary outcomes (1)
The number of volunteers with adverse events as a measure of safety and tolerability
The number of volunteers with adverse events as a measure of safety and tolerability
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 posted19 May 2017
- Study startJun 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT03160014
- Sponsor's protocol ID
- SHR3824-109
- Status last verified
- Jun 2016
- First submitted
- 17 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment (Single-Center, Open-label, Parallel-Group, Single-Dose Study)
- ClinicalTrials.gov ID
- NCT03160014
- Acronym / sponsor ID
- SHR3824-109
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 19 May 2017 (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.
Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Drug: SHR3824Drug: SHR3824 20mg/day, oral tablet, single dose |
| Mild Hepatic Impairment | Experimental | Drug: SHR3824Drug: SHR3824 20mg/day, oral tablet, single dose |
| Moderate Hepatic Impairment | Experimental | Drug: SHR3824Drug: SHR3824 20mg/day, oral tablet, single dose |
| Severe Hepatic Impairment | Experimental | Drug: SHR3824Drug: SHR3824 20mg/day, oral tablet, single dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years to 75 years (inclusive)
- Body mass index should be between 18 and 33 kg/m2 (inclusive) (ie, a measure of one's weight in relation to height)
- Liver damage due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis of the liver (except for patients with drug-induced liver injury)
Key exclusion criteria (4 listed)
- allergic to SGLT2 inhibitor analogues or any other similar structure;
- lactose intolerance history or lactose intolerance;
- Suspected or diagnosed as liver cancer or with other malignant tumors;
- Alcoholic liver, autoimmune liver disease, liver transplantation history
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 |
|---|---|---|
| SHR3824Drug: SHR3824 20mg/day, oral tablet, single dose | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, Severe Hepatic Impairment, healthy volunteers |
Primary outcome
The area under the plasma concentration-time curve (AUC) of SHR3824
Time frame: 72 hours after dosing
AUC (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients
The maximum plasma concentration (Cmax) of SHR3824
Time frame: 72 hours after dosing
Cmax (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients.
1 secondary outcome
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: 72 hours after dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
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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.
XinMin Zhou contact
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 SHR3824 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 3 inclusion and 4 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 19 May 2017. 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?
Contact XinMin Zhou (029-84775507), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the plasma concentration-time curve (AUC) of SHR3824 (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 19 May 2017.