The DDI Study of SP2086 and Simvastatin

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: SP2086; Drug: Simvastatin

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • the First Hosital of Jilin University
      • Contact: Yanhua Ding, docter; Phone Number: 0431-88782168; Email: dingyanhua2003@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: SP2086 and 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.

Drug: 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.; Drug: 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.

What is the study measuring?

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 a single dose of Simvastatin.	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.	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	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.	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.	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.	up to Day 9

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of volunteers with adverse events as a measure of safety and tolerability	up to Day 9

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Estimate): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: SP2086-112