Type 2 DiabetesPhase 1NCT03329118
Drug-drug Interaction Between Simvastatin and SHR3824
A Phase 1 study testing SHR3824, Simvastatin in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
the purpose of thr study is to investigate the potential interation between multiple oral doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SHR3824, Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2017to 8 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2
Who cannot join
- History of hypoglycemia
- History of urinary tract infections,or genital infections
- History of current clinically significant medical illness as determined by the Investigator
- Known allergy to SHR3824 or Simvastatin or any of the excipients of the formulation of SHR3824 or Simvastatin
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Drug Interaction Study of Henagliflozin and Simvastatin in Healthy Volunteers
the purpose of thr study is to investigate the potential interation between multiple oral doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers.
- Conditions
- Type 2 Diabetes
- Being tested
- SHR3824, Simvastatin
- Keywords
- SHR3824,simvastatin, drug-drug interaction
- 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.
SHR3824, SimvastatinDrug
two 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8.
| Study group | Role | What they receive |
|---|---|---|
| SHR3824 1Omg,Simavastatin 40mg | Experimental | two 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8. Receives: Drug: SHR3824, Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax) of SHR3824
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin .
Measured: At protocol-specified times up to Day 7 and Day 8
The area under the plasma concentration-time curve (AUC) of SHR3824
AUC(a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin .
Measured: At protocol-specified times up to Day 7 and Day 8
The area under the plasma concentration-time curve (AUC) of Simvastatin and simavastatin acid .
AUC(a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with SHR3824 .
Measured: At protocol-specified times up to Day 1 and Day 8
The maximum plasma concentration (Cmax) of simvastatin and simavastatin acid.
Cmax (a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with Simvastatin .
Measured: At protocol-specified times up to Day 1 and Day 8
The number of volunteers with adverse events as a measure of safety and tolerability.
Measured: up to day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start24 Nov 2017 (estimated)
- Primary completion4 Dec 2017 (estimated)
- Study completion8 Dec 2017 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT03329118
- Sponsor's protocol ID
- SHR3824-111
- Status last verified
- Oct 2017
- First submitted
- 30 Oct 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Interaction Study of Henagliflozin and Simvastatin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03329118
- Acronym / sponsor ID
- SHR3824-111
- Conditions
- Type 2 Diabetes
- Keywords
- SHR3824,simvastatin, drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2017 (estimated)
- Primary completion
- 4 Dec 2017 (estimated)
- Study completion
- 8 Dec 2017 (estimated)
- First posted
- 1 Nov 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 thr study is to investigate the potential interation between multiple oral doses of SHR3824 and single oral dose of Simvastatin in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR3824 1Omg,Simavastatin 40mg | Experimental | Drug: SHR3824, Simvastatintwo 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2
Key exclusion criteria (4 listed)
- History of hypoglycemia
- History of urinary tract infections,or genital infections
- History of current clinically significant medical illness as determined by the Investigator
- Known allergy to SHR3824 or Simvastatin or any of the excipients of the formulation of SHR3824 or Simvastatin
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 |
|---|---|---|
| SHR3824, Simvastatintwo 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8. | Drug | SHR3824 1Omg,Simavastatin 40mg |
Primary outcome
The maximum plasma concentration (Cmax) of SHR3824
Time frame: At protocol-specified times up to Day 7 and Day 8
Cmax (a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin .
The area under the plasma concentration-time curve (AUC) of SHR3824
Time frame: At protocol-specified times up to Day 7 and Day 8
AUC(a measure of the body's exposure to SHR3824) will be compared before and after coadministration with Simvastatin .
The area under the plasma concentration-time curve (AUC) of Simvastatin and simavastatin acid .
Time frame: At protocol-specified times up to Day 1 and Day 8
AUC(a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with SHR3824 .
The maximum plasma concentration (Cmax) of simvastatin and simavastatin acid.
Time frame: At protocol-specified times up to Day 1 and Day 8
Cmax (a measure of the body's exposure to simvastatin and simavastatin acid) will be compared before and after coadministration with Simvastatin .
The number of volunteers with adverse events as a measure of safety and tolerability.
Time frame: up to day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR3824, Simvastatin in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..
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 1 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 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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, liuhaiyan@shhrp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum plasma concentration (Cmax) of SHR3824 (time frame: At protocol-specified times up to Day 7 and Day 8). The study lists 5 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 9 Nov 2017.