Type 2 DiabetesPhase 1NCT02817243

The DDI Study of SP2086 and Simvastatin

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

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of the study is to investigate the potential interaction between multiple oral doses of SP2086 and a 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?: SP2086 and Simvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: Mar 2016to Jul 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 metformin or any of the excipients of the formulation of SP2086 or Simvastatin

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

the First Hosital of Jilin University
Changchun, Jilin
Yanhua Ding, docter, 0431-88782168, dingyanhua2003@126.com
Recruiting

Other trials in China

About this study

Official title: The Drug Interaction Study of SP2086 and Simvastatin in Healthy Subjects

The purpose of the study is to investigate the potential interaction between multiple oral doses of SP2086 and a single oral dose of Simvastatin in healthy adult volunteers.

Read the detailed description

This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SP2086 and Simvastatin in healthy adult volunteers. SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.

Conditions: Type 2 Diabetes
Being tested: SP2086, Simvastatin
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 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.
SimvastatinDrug
SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.

Study groups in NCT02817243
Study group	Role	What they receive
SP2086 and Simvastatin	Other	SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water. Receives: Drug: SP2086; Drug: Simvastatin

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 Simvastatin.
Measured: up to Day 9
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 Simvastatin.
Measured: up to Day 9
The maximum plasma concentration (Cmax) of Simvastatin
Cmax (a measure of the body's exposure to Simvastatin) will be compared. before and after administration of multiple doses of SP2086
Measured: up to Day 9
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 Simvastatin.
Measured: up to Day 9
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 Simvastatin.
Measured: up to Day 9
The area under the plasma concentration-time curve (AUC) of Simvastatin
AUC (a measure of the body's exposure to Simvastatin) will be compared before and after administration of multiple doses of SP2086.
Measured: up to Day 9

Secondary outcomes (1)

The number of volunteers with adverse events as a measure of safety and tolerability
Measured: up to Day 9

Timeline

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

Mar 2016Jul 2016

First posted29 Jun 2016 (estimated)
Study startMar 2016
Primary completionJul 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02817243
Sponsor's protocol ID: SP2086-112
Status last verified: Mar 2016
First submitted: 27 Jun 2016
Last updated: 29 Jun 2016
Results posted: No
Data monitoring committee: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

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 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Drug Interaction Study of SP2086 and Simvastatin in Healthy Subjects
ClinicalTrials.gov ID: NCT02817243
Acronym / sponsor ID: SP2086-112
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: Jul 2016 (estimated)
First posted: 29 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 potential interaction between multiple oral doses of SP2086 and a single oral dose of Simvastatin in healthy adult volunteers.

Detailed description

Study design

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

Arm	Type	Receives
SP2086 and Simvastatin	Other	Drug: SP2086, Drug: SimvastatinSP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.

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
SP2086SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.	Drug	SP2086 and Simvastatin
SimvastatinSP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.	Drug	SP2086 and Simvastatin

Primary outcome

The maximum plasma concentration (Cmax) of SP2086
Time frame: up to Day 9
Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Simvastatin.
The maximum plasma concentration (Cmax) of SP2086 acid
Time frame: up to Day 9
Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Simvastatin.
The maximum plasma concentration (Cmax) of Simvastatin
Time frame: up to Day 9
Cmax (a measure of the body's exposure to Simvastatin) 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 Day 9
AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Simvastatin.
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Time frame: up to Day 9
AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Simvastatin.
The area under the plasma concentration-time curve (AUC) of Simvastatin
Time frame: up to Day 9
AUC (a measure of the body's exposure to Simvastatin) 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 Day 9

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 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.

the First Hosital of Jilin University

Changchun, China

0431-88782168

dingyanhua2003@126.com

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 Simvastatin 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 29 Jun 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?

Each site lists its own contact: choose the nearest one under Trial locations. 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 9). 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?

On the ClinicalTrials.gov record for NCT02817243.

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 29 Jun 2016.