The DDI Study of SP2086 and Simvastatin

Phase 1

• Conditions: Type 2 Diabetes
• Interventions: Drug: SP2086; Drug: Simvastatin

• Registration Number: NCT02817243
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

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.

Study Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-28
• Last Update Submitted: 2016-06-28
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SP2086 and Simvastatin	SP2086	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.
SP2086 and Simvastatin	Simvastatin	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.

Primary Outcome Measures

Name	Time	Method
The maximum plasma concentration (Cmax) of SP2086	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	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 9

Trial Locations

Locations (1)

the First Hosital of Jilin University; 🇨🇳 Changchun, Jilin, China