The Metabolite Identification and Material Balance Study of SP2086

A Phase 1 study testing SP2086 in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd..

Completed

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

Trial summary

The purpose of the study is to investigate the Metabolite identification and material balance of SP2086 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?: SP2086
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: No sites listed yet
Study dates: Aug 2015to Oct 2015
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) between 19 and 25 Kg/m2,and weight ≥50kg.
Lab and other examination results were normal or mildly abnormal without clinical significance, clinical doctors had considered eligible.
Had signed the informed consent himself or herself voluntarily.

Who cannot join

Has a history of severe system disease, or family history (including the cardiovascular system, digestive system, urinary system, etc.).
Has a history of allergy or intolerance to SP2086 OR other DPP-IV.
The subjects participated 3 times or more than 3 times drug clinical subjects in nearly a year;participate any drug clinical trial prior to the test 3 months, or had blood donor, or plan to blood donors three months before the test;or had a transfusion in 4 weeks.
Did not take effective contraceptive measures or planning of the subjects in half a year.
Researchers considered the patient adherence is poor, or has any unfavorable factors that not suit to participate the test.

About this study

Official title: A Single-center, Randomized, Open, Single Dose Phase I Study to Access the Metabolite Identification and Material Balance in Health Volunteer

The purpose of the study is to investigate the Metabolite identification and material balance of SP2086 in healthy adult volunteers.

Read the detailed description

All subjects were given SP2086 100mg only one time, and blood sample should be collected before and 96 hours after medicine taken.

Conditions: Type 2 Diabetes
Being tested: SP2086
Keywords: SP2086, Metabolite identification, Material balance
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
SP2086 was taken only one time at 100mg dose in health volunteers

Study groups in NCT02815748
Study group	Role	What they receive
SP2086	Other	SP2086 was taken only one time at 100mg dose in health volunteers 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 multiple doses of SP2086
Measured: up to 96 hours
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 multiple doses of SP2086
Measured: up to 96 hours
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 multiple doses of SP2086
Measured: up to 96 hours
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 multiple doses of SP2086
Measured: up to 96 hours

Secondary outcomes (1)

The number of volunteers with adverse events as a measure of safety and tolerability
Measured: up to 96 hours

Timeline

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

Aug 2015Oct 2015

First posted28 Jun 2016 (estimated)
Study startAug 2015
Primary completionOct 2015
Study completionOct 2015

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: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02815748
Sponsor's protocol ID: HR-SP2086-109
Status last verified: Jun 2016
First submitted: 3 Jan 2016
Last updated: 1 Jul 2016
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?

Official record

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)

All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Randomized, Open, Single Dose Phase I Study to Access the Metabolite Identification and Material Balance in Health Volunteer
ClinicalTrials.gov ID: NCT02815748
Acronym / sponsor ID: HR-SP2086-109
Conditions: Type 2 Diabetes
Keywords: SP2086, Metabolite identification, Material balance
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: Aug 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 28 Jun 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.

The purpose of the study is to investigate the Metabolite identification and material balance of SP2086 in healthy adult volunteers.

Detailed description

All subjects were given SP2086 100mg only one time, and blood sample should be collected before and 96 hours after medicine taken.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SP2086	Other	Drug: SP2086SP2086 was taken only one time at 100mg dose in health volunteers

Who may qualify

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

Key inclusion criteria (3 listed)

Healthy volunteers with a body mass index(BMI) between 19 and 25 Kg/m2,and weight ≥50kg.
Lab and other examination results were normal or mildly abnormal without clinical significance, clinical doctors had considered eligible.
Had signed the informed consent himself or herself voluntarily.

Key exclusion criteria (5 listed)

Has a history of severe system disease, or family history (including the cardiovascular system, digestive system, urinary system, etc.).
Has a history of allergy or intolerance to SP2086 OR other DPP-IV.
The subjects participated 3 times or more than 3 times drug clinical subjects in nearly a year;participate any drug clinical trial prior to the test 3 months, or had blood donor, or plan to blood donors three months before the test;or had a transfusion in 4 weeks.
Did not take effective contraceptive measures or planning of the subjects in half a year.
Researchers considered the patient adherence is poor, or has any unfavorable factors that not suit to participate the test.

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
SP2086SP2086 was taken only one time at 100mg dose in health volunteers	Drug	SP2086

Primary outcome

The maximum plasma concentration (Cmax) of SP2086
Time frame: up to 96 hours
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
The maximum plasma concentration (Cmax) of SP2086 acid
Time frame: up to 96 hours
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086
Time frame: up to 96 hours
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Time frame: up to 96 hours
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086

1 secondary outcome

The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to 96 hours

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 1 Jul 2016.

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.

XingHe Wang, P.H.D principal investigator

Beijing Shijitan Hospital, Capital Medical University

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SP2086 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 3 inclusion and 5 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 1 Jul 2016. 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 SP2086 (time frame: up to 96 hours). The study lists 4 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 NCT02815748.

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 1 Jul 2016.