Type 2 DiabetesPhase 1NCT02821871
the Food Effect Pharmacokinetic, Material Balance and Metabolite Identification of SP2086 in Healthy Volunteers
A Phase 1 study testing SP2086 and high fat diet in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
All eligible subjects were randomly assigned to group A and group B sequences, each sequence has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study ,the investigators collected the blood samples,urine samples and fecal samples to analyze. 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?
- SP2086 and high fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Sep 2016
- 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 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 diabetes
- History of heart failure or renal insufficiency
- Urinary tract infections, or vulvovaginal mycotic infections
- 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 SP2086 or any of the excipients of the formulation of SP2086
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Haichun Ma, Ph.D
About this study
All eligible subjects were randomly assigned to group A and group B sequences, each sequence has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study ,the investigators collected the blood samples,urine samples and fecal samples to analyze.
- Conditions
- Type 2 Diabetes
- Being tested
- SP2086, high fat diet
- 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.
SP2086Drug
high fat dietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| SP2086 | Active comparator | All subjects were ransomed to A and B sequence.In A sequence,subjects take SP2086 100mg once in fasting the first day,and the B sequence subjects need to take SP2086 100mg after the high fat diet.In Day 8，the medicine strategy of two sequence subjects were alternately. Receives: Dietary Supplement: high fat diet |
| high fat diet | Other | All subjects were ransomed to A and B sequence.In A sequence,subjects take SP2086 100mg once in fasting the first day,and the B sequence subjects need to take SP2086 100mg after the high fat diet.In Day 8，the medicine strategy of two sequence subjects were alternately. Receives: Drug: SP2086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax) of SP2086
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
Measured: up to Day 12
The maximum plasma concentration (Cmax) of SP2086 acid
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086.
Measured: up to Day 12
The area under the plasma concentration-time curve (AUC) of SP2086
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086.
Measured: up to Day 12
The area under the plasma concentration-time curve (AUC) of SP2086 acid
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086.
Measured: up to Day 12
Cumulative percentage drainage of SP2086 in urine
Measured: up to Day 12
Cumulative percentage drainage of SP2086 in fecal
Measured: up to Day 12
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 posted4 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (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
- Randomised
- Intervention model
- Crossover
- 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
- NCT02821871
- Sponsor's protocol ID
- SP2086-110
- Status last verified
- Jun 2016
- First submitted
- 26 Jun 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Food Effect Pharmacokinetic, Material Balance and Metabolite Identification of SP2086 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02821871
- Acronym / sponsor ID
- SP2086-110
- Conditions
- 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
- Mar 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 4 Jul 2016 (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.
All eligible subjects were randomly assigned to group A and group B sequences, each sequence has 12 subjects. The SP2086 were given limosis,then after the meal,then limosis.In the study ,the investigators collected the blood samples,urine samples and fecal samples to analyze.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP2086 | Active comparator | Dietary Supplement: high fat dietAll subjects were ransomed to A and B sequence.In A sequence,subjects take SP2086 100mg once in fasting the first day,and the B sequence subjects need to take SP2086 100mg after the high fat diet.In Day 8，the medicine strategy of two sequence subjects were alternately. |
| high fat diet | Other | Drug: SP2086All subjects were ransomed to A and B sequence.In A sequence,subjects take SP2086 100mg once in fasting the first day,and the B sequence subjects need to take SP2086 100mg after the high fat diet.In Day 8，the medicine strategy of two sequence subjects were alternately. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy 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 (6 listed)
- History of diabetes
- History of heart failure or renal insufficiency
- Urinary tract infections, or vulvovaginal mycotic infections
- 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 |
|---|---|---|
| SP2086 | Drug | high fat diet |
| high fat diet | Dietary supplement | SP2086 |
Primary outcome
The maximum plasma concentration (Cmax) of SP2086
Time frame: up to Day 12
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086
The maximum plasma concentration (Cmax) of SP2086 acid
Time frame: up to Day 12
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086.
The area under the plasma concentration-time curve (AUC) of SP2086
Time frame: up to Day 12
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of SP2086.
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Time frame: up to Day 12
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of SP2086.
Cumulative percentage drainage of SP2086 in urine
Time frame: up to Day 12
Cumulative percentage drainage of SP2086 in fecal
Time frame: up to Day 12
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
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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.
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 SP2086 and high fat diet 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 1 inclusion and 6 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 4 Jul 2016. 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 Yanhua Ding, docter (0431-88782168, dingyanhua2003@126.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 SP2086 (time frame: up to Day 12). The study lists 6 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 4 Jul 2016.