The Drug-drug Interaction of SP2086 and Simvastatin

Study Overview
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Brief Summary
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The purpose of the study is to investigate the potential interaction between SP2086 and Simvastatin after the multiple oral doses treatment in healthy adult volunteers.

Detailed Description
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This is an open-label (volunteers will know the names of treatments they are assigned) single-center and cross-over study of SP2086 and Simvastatin in healthy adult volunteers. All subject were randomized into two groups, and the drugs will be administered according to the AB and BA sequences. The A sequence was that SP2086 was taken at 40mg qd on Day1-Day 10; Simvastatin will be administered orally (by mouth) as 200mg on Day 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd on Day6-Day10. There were 5 days washout period between A and B. The total time of this trial was 27 days.

Official Title
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A Single Randomized, Open,Cross-over, Phase Ig Study to Access the Drug-drug Interaction of SP2086 and Simvastatin

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: SP2086
* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers with a body mass index(BMI) between 19 and 24 Kg/m2 Had signed the informed consent himself or herself voluntarily. Exclusion Criteria: Have the abnormal lab or other examination results and the change have clinical significance. History of or current clinically significant medical illness as determined by the Investigator. Have a family history of thyroid cancer, submandibular gland cancer or long QT syndrome Known allergy to SP2086 or Glyburide or any of the excipients of the formulation of SP2086 or Glyburide. History of using the sulfa or sulfonylureas or DPP-IVor GLP-1 drugs or other similar structure drugs. History of severe unconsciousness hypoglycemia History of any surgery prior to screening in 6 months. History of blood donation≥400 mL prior to screening in 3 months or participate in blood donation,or by blood transfusion in one month. History of participate any drug or medical device prior to screening in 3 months. Within a month before the screening using any prescription drugs, over-the-counter drugs, Chinese herbal medicine (especially oral antidiabetics drugs) or food supplements( vitamins). 2 days before the randomization ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion. The hepatitis B surface antigen, hepatitis c antibody, HIV antibody and syphilis antibody was positive. Pregnancy or lactation women, or a fertility male or female is not willing to contraception during test. Researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SP2086 and Simvastatin<br>All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.There were 5 days washout period between the two stages.The whole study needs 27 days.This group patient was given treatment from A stage to B stage. | Drug: SP2086<br>* The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.<br>Drug: Simvastatin<br>* The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.<br>|
| Active Comparator: Simvastatin and SP2086<br>All subject were randomized into two groups,and the drugs will be administered according to the AB and BA sequences,all subjects must completed the two stages(A and B).The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.There were 5 days washout period between the two stages.The whole study needs 27 days.This group patient was given treatment from B stage to A stage. | Drug: SP2086<br>* The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.<br>Drug: Simvastatin<br>* The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to Day 27 | 
| 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 | up to Day 27 | 
| 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 Simvastatin | up to Day 27 | 
| 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 | up to Day 27 | 
| 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 | up to Day 27 | 
| 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 Simvastatin | up to Day 27 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of volunteers with adverse events as a measure of safety and tolerability |  | up to Day 27 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SP2086, Simvastatin, drug-drug interaction