Type 2 DiabetesPhase 1NCT02361138

The PK/PD Study of Multiple Dose of SHR3824 in Healthy Volunteers

A Phase 1 study testing SHR3824 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes
What is being tested?: SHR3824
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteChina
Study dates: Dec 2013to May 2014
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Chinese male and female subjects aged 18 to 45 years.
BMI:18 -25 kg/m2.
Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.

Who cannot join

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.
Pregnancy or breastfeeding . Significant acute or chronic medical illness, including renal impairment, or recent surgery.
Donation of blood or plasma within the 4 weeks prior to the start of the study or acceptance of blood transfusion within 8 weeks.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following Multiple Dose of SHR3824 in Healthy Subjects

Conditions: Type 2 Diabetes
Being tested: SHR3824, Placebo
Keywords: SHR3824 Type 2 diabetes mellitus SGLT2
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR3824Drug
Also called Henagliflozin
PlaceboDrug

Study groups in NCT02361138
Study group	Role	What they receive
Cohort SHR3824/Placebo 1.25 mg	Experimental	SHR3824 1.25 mg/day or placebo for 10 days. Receives: Drug: SHR3824; Drug: Placebo
Cohort SHR3824/Placebo 2.5 mg	Experimental	SHR3824 2.5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort. Receives: Drug: SHR3824; Drug: Placebo
Cohort SHR3824/Placebo 5 mg	Experimental	SHR3824 5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort. Receives: Drug: SHR3824; Drug: Placebo
Cohort SHR3824/Placebo 10 mg	Experimental	SHR3824 10 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort. Receives: Drug: SHR3824; Drug: Placebo
Cohort SHR3824/Placebo 25 mg	Experimental	SHR3824 25 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort. Receives: Drug: SHR3824; Drug: Placebo
Cohort SHR3824/Placebo 100mg	Experimental	SHR3824 100 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort. Receives: Drug: SHR3824; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC(Area under the curve) of SHR3824.
Measured: day1 and day11 to day 13.
Cmax(the maximum concentration) of SHR3824.
Measured: day1 and day11 to day 13.
Tmax(the time reaching maximum concentration) of SHR3824.
Measured: day1 and day11 to day 13.
Halflife of SHR3824.
Measured: day1 and day11 to day 13.
CL/F of SHR3824.
Measured: day1 and day11 to day 13.
V/F of SHR3824.
Measured: day1 and day11 to day 13.
Accumulation ratio of SHR3824
Measured: Up to day 13.
Urine glucose concentration of SHR3824.
Measured: day1 and day11
Plasma glucose concentration of SHR3824.
Measured: day1 and day11

Secondary outcomes (2)

Adverse events, vital signs, physical exams , ECG, clinical labs
Measured: Days -14 to -1, 0, 13.
Serum creatinine
Measured: Days -14 to -1, 0, 2, 9, 13.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013May 2014

First posted11 Feb 2015 (estimated)
Study startDec 2013
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02361138
Sponsor's protocol ID: SHR3824-102
Status last verified: Dec 2014
First submitted: 1 Feb 2015
Last updated: 11 Feb 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following Multiple Dose of SHR3824 in Healthy Subjects
ClinicalTrials.gov ID: NCT02361138
Acronym / sponsor ID: SHR3824-102
Conditions: Type 2 Diabetes
Keywords: SHR3824 Type 2 diabetes mellitus SGLT2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 11 Feb 2015 (estimated)
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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Cohort SHR3824/Placebo 1.25 mg	Experimental	Drug: SHR3824, Drug: PlaceboSHR3824 1.25 mg/day or placebo for 10 days.
Cohort SHR3824/Placebo 2.5 mg	Experimental	Drug: SHR3824, Drug: PlaceboSHR3824 2.5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 5 mg	Experimental	Drug: SHR3824, Drug: PlaceboSHR3824 5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 10 mg	Experimental	Drug: SHR3824, Drug: PlaceboSHR3824 10 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 25 mg	Experimental	Drug: SHR3824, Drug: PlaceboSHR3824 25 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.
Cohort SHR3824/Placebo 100mg	Experimental	Drug: SHR3824, Drug: PlaceboSHR3824 100 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Chinese male and female subjects aged 18 to 45 years.
BMI:18 -25 kg/m2.
Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.

Key exclusion criteria (4 listed)

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.
Pregnancy or breastfeeding . Significant acute or chronic medical illness, including renal impairment, or recent surgery.
Donation of blood or plasma within the 4 weeks prior to the start of the study or acceptance of blood transfusion within 8 weeks.

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
SHR3824Also: Henagliflozin	Drug	Cohort SHR3824/Placebo 1.25 mg, Cohort SHR3824/Placebo 10 mg, Cohort SHR3824/Placebo 100mg, Cohort SHR3824/Placebo 2.5 mg, Cohort SHR3824/Placebo 25 mg, Cohort SHR3824/Placebo 5 mg
Placebo	Drug	Cohort SHR3824/Placebo 1.25 mg, Cohort SHR3824/Placebo 10 mg, Cohort SHR3824/Placebo 100mg, Cohort SHR3824/Placebo 2.5 mg, Cohort SHR3824/Placebo 25 mg, Cohort SHR3824/Placebo 5 mg

Primary outcome

AUC(Area under the curve) of SHR3824.
Time frame: day1 and day11 to day 13.
Cmax(the maximum concentration) of SHR3824.
Time frame: day1 and day11 to day 13.
Tmax(the time reaching maximum concentration) of SHR3824.
Time frame: day1 and day11 to day 13.
Halflife of SHR3824.
Time frame: day1 and day11 to day 13.
CL/F of SHR3824.
Time frame: day1 and day11 to day 13.
V/F of SHR3824.
Time frame: day1 and day11 to day 13.
Accumulation ratio of SHR3824
Time frame: Up to day 13.
Urine glucose concentration of SHR3824.
Time frame: day1 and day11
Plasma glucose concentration of SHR3824.
Time frame: day1 and day11

2 secondary outcomes

Adverse events, vital signs, physical exams , ECG, clinical labs
Time frame: Days -14 to -1, 0, 13.
Serum creatinine
Time frame: Days -14 to -1, 0, 2, 9, 13.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.

Related trials for Type 2 Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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 SHR3824 in people with 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 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: finished, as of the sponsor's last update on 11 Feb 2015. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

AUC(Area under the curve) of SHR3824. (time frame: day1 and day11 to day 13.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02361138.

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 11 Feb 2015.