Type 2 DiabetesPhase 1NCT02353975
Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects
A Phase 1 study testing SHR3824 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects. 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
- 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
- May 2014to Sep 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy.
- BMI 18-25 kg/m2.
Who cannot join
- History of clinically significant illness.
- History of alcohol or drug abuse.
About this study
Official title: An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR3824 and Mass Balance Study in Healthy Volunteers
This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.
- Conditions
- Type 2 Diabetes
- Being tested
- SHR3824
- Keywords
- SHR3824, food effect, mass, balance, Phase I
- Medical subject headings
- Diabetes Mellitus, Type 2, Arachnodactyly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR3824Drug
SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.
| Study group | Role | What they receive |
|---|---|---|
| SHR3824 10mg fasted to fed | Experimental | SHR3824 tablet, fasting conditions day 1, visit 2, 7 days wash-out, SHR3824 tablet, high fat, high calorie breakfast day 1, visit 3. Receives: Drug: SHR3824 |
| SHR3824 10mg fed to fasted | Experimental | SHR3824, high fat, high calorie breakfast day 1, visit 2, 7 days wash-out, SHR3824, fasting conditions day 1, visit 3. Receives: Drug: SHR3824 |
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 under fating state and fasted state
Measured: Day 1-4 on visit 2 and visit 3
The area under the plasma concentration-time curve (AUC) of SHR3824
AUC (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state
Measured: Day 1-4 on visit 2 and visit 3
The accumulative excretion rate of SHR3824 and its metabolites in urine and feces
Accumulative excretion rate will be compared under fating state and fasted state
Measured: Day 1-4 on visit 2 and visit 3
Secondary outcomes (1)
The number of volunteers with adverse events as a measure of safety and tolerability.
Measured: Up to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionSep 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02353975
- Sponsor's protocol ID
- SHR3824-104
- Status last verified
- Jan 2015
- First submitted
- 20 Jan 2015
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR3824 and Mass Balance Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02353975
- Acronym / sponsor ID
- SHR3824-104
- Conditions
- Type 2 Diabetes
- Keywords
- SHR3824, food effect, mass, balance, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 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.
This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR3824 10mg fasted to fed | Experimental | Drug: SHR3824SHR3824 tablet, fasting conditions day 1, visit 2, 7 days wash-out, SHR3824 tablet, high fat, high calorie breakfast day 1, visit 3. |
| SHR3824 10mg fed to fasted | Experimental | Drug: SHR3824SHR3824, high fat, high calorie breakfast day 1, visit 2, 7 days wash-out, SHR3824, fasting conditions day 1, visit 3. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy.
- BMI 18-25 kg/m2.
Key exclusion criteria (2 listed)
- History of clinically significant illness.
- History of alcohol or drug abuse.
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 |
|---|---|---|
| SHR3824SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast. | Drug | SHR3824 10mg fasted to fed, SHR3824 10mg fed to fasted |
Primary outcome
The maximum plasma concentration (Cmax) of SHR3824
Time frame: Day 1-4 on visit 2 and visit 3
Cmax (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state
The area under the plasma concentration-time curve (AUC) of SHR3824
Time frame: Day 1-4 on visit 2 and visit 3
AUC (a measure of the body's exposure to SHR3824) will be compared under fating state and fasted state
The accumulative excretion rate of SHR3824 and its metabolites in urine and feces
Time frame: Day 1-4 on visit 2 and visit 3
Accumulative excretion rate will be compared under fating state and fasted state
1 secondary outcome
The number of volunteers with adverse events as a measure of safety and tolerability.
Time frame: Up to Day 12
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 3 Feb 2015.
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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.
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..
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 2 inclusion and 2 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 3 Feb 2015. 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?
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?
The maximum plasma concentration (Cmax) of SHR3824 (time frame: Day 1-4 on visit 2 and visit 3). The study lists 3 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 3 Feb 2015.