Renal Insufficiency,Type 2 DiabetesPhase 1NCT03159832
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient
A Phase 1 study testing SHR3824 in people with Renal Insufficiency,Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Insufficiency,Type 2 Diabetes
- What is being tested?
- SHR3824
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with a body mass index(BMI) between 19 and 33 Kg/m2;
- The estimated glomerular filtration rate (eGFR)of subjects in groups must meet the corresponding standards:mild renal insufficiency:60 to 89 ml/min/1.73m2;Moderate renal insufficiency: 30 to 59 ml/min/1.73m2.
- Had signed the informed consent himself or herself voluntarily.
Who cannot join
- Urinary tract infections, or vulvovaginal mycotic infections
- Suspected or diagnosed as kidney cancer or other malignancies in patients
- Autoimmune kidney disease, history of renal transplantation, dialysis patients being treated
- History of or current clinically significant medical illness as determined by the Investigator
- History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
- Known allergy to SHR3824,SGLT2 inhibitor analogs, or any other structural analogs
Show all 9Show fewer
- Alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;Tobacco is defined as five or more per day.
- Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test.
- Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.
Trial locations and contacts
1 site in 1 country.
Haiyan Liu, Phd contact
China1 site, 1 recruiting
- Recruiting
Chinese people's liberation army general hospital of Chengdu military area
Chengdu, Sichuan
xiaolan yong
About this study
Official title: Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Type 2 Diabetes Patients With Renal Insufficient (Open-label, Parallel-Group, Single-Dose Study)
The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.
Read the detailed description
This trial was a parallel, open-label, single dose study. The subject was divided into one of three groups according to the degree of renal Insufficiency,including normal, mild and moderate. All subjects were given SHR3824 20mg, the blood and urine samples were collected before and after dosing.
- Conditions
- Renal Insufficiency,Type 2 Diabetes
- Being tested
- SHR3824
- Keywords
- Efficacy, PK/PD study, Renal Insufficiency, Type 2 Diabetes
- Medical subject headings
- Renal Insufficiency, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR3824Drug
All subjects were given SHR3824 20mg only one time.
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Active comparator | All subjects were given SHR3824 20mg only one time. Receives: Drug: SHR3824 |
| Mild renal dysfunction | Active comparator | All subjects were given SHR3824 20mg only one time. Receives: Drug: SHR3824 |
| Moderate renal dysfunction | Active comparator | All subjects were given SHR3824 20mg only one time. 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 renal function patients and mild or moderate renal 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 renal function patients and mild or moderate renal 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 Renal Insufficiency,Type 2 DiabetesStudies 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 (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
- NCT03159832
- Sponsor's protocol ID
- SHR3824-110
- Status last verified
- Jun 2016
- First submitted
- 17 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- 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 Type 2 Diabetes Patients With Renal Insufficient (Open-label, Parallel-Group, Single-Dose Study)
- ClinicalTrials.gov ID
- NCT03159832
- Acronym / sponsor ID
- SHR3824-110
- Conditions
- Renal Insufficiency,Type 2 Diabetes
- Keywords
- Efficacy, PK/PD study, Renal Insufficiency, Type 2 Diabetes
- 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
- 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.
The purpose of the study is to investigate the pharmacokinetics/pharmacodynamics and safety of SHR3824 in Type 2 Diabetes Patients with Renal Insufficient.
Detailed description
This trial was a parallel, open-label, single dose study. The subject was divided into one of three groups according to the degree of renal Insufficiency,including normal, mild and moderate. All subjects were given SHR3824 20mg, the blood and urine samples were collected before and after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Active comparator | Drug: SHR3824All subjects were given SHR3824 20mg only one time. |
| Mild renal dysfunction | Active comparator | Drug: SHR3824All subjects were given SHR3824 20mg only one time. |
| Moderate renal dysfunction | Active comparator | Drug: SHR3824All subjects were given SHR3824 20mg only one time. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- with a body mass index(BMI) between 19 and 33 Kg/m2;
- The estimated glomerular filtration rate (eGFR)of subjects in groups must meet the corresponding standards:mild renal insufficiency:60 to 89 ml/min/1.73m2;Moderate renal insufficiency: 30 to 59 ml/min/1.73m2.
- Had signed the informed consent himself or herself voluntarily.
Key exclusion criteria (9 listed)
- Urinary tract infections, or vulvovaginal mycotic infections
- Suspected or diagnosed as kidney cancer or other malignancies in patients
- Autoimmune kidney disease, history of renal transplantation, dialysis patients being treated
- History of or current clinically significant medical illness as determined by the Investigator
- History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
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 |
|---|---|---|
| SHR3824All subjects were given SHR3824 20mg only one time. | Drug | Mild renal dysfunction, Moderate renal dysfunction, Normal renal function |
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 renal function patients and mild or moderate renal 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 renal function patients and mild or moderate renal 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.
Haiyan Liu, Phd 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 Renal Insufficiency,Type 2 Diabetes, 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 9 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 Haiyan Liu, Phd (+86-15705155025), 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.