The Drug-drug Interaction of SHR3824 and SP2086

Phase 1

• Conditions: Type 2 Diabetes
• Interventions: Drug: SHR3824, SP2086

• Registration Number: NCT02500485
• 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 SHR3824 and multiple oral doses of SP2086 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 SHR3824 and SP2086 in healthy adult volunteers. SHR3824(a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) ,and SP2086(a Dipeptidyl peptidase IV inhibitor) is also currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM).SP2086 will be administered orally (by mouth) as 100mg on Days 1, 2, 3, 4, 15, 16, 17 and 18, SHR3824 will be administered orally (by mouth) as 20mg on Days 11, 12, 13, 14, 15, 16, 17 and 18. Both SHR3824 and SP2086 tablets will be taken with 8 ounces (240 mL) of water.

Study Timeline

• Study Start: 2015-05
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Last Update Submitted: 2015-11-23
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 24 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 SHR3824 or SP2086 or any of the excipients of the formulation of SHR3824 or SP2086

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR3824 20mg/SP2086 100mg	SHR3824, SP2086	One 100-mg tablet of SP2086 once daily on Day 1,2,3,4 followed by two 10-mg tablets of SHR3824 once daily on Day 11,12,13,14, followed by one 100-mg tablet of SP2086 and two 10-mg tablets of SHR3824 on Day 15,16,17,18.

Primary Outcome Measures

Name	Time	Method
The maximum plasma concentration (Cmax) of SHR3824.	At protocol-specified times up to Day 14 and Day 18.	Cmax (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086.
The area under the plasma concentration-time curve (AUC) of SHR3824.	At protocol-specified times up to Day 14 and Day 18.	AUC (a measure of the body's exposure to SHR3824) will be compared before and after administration of multiple doses of SP2086.
The maximum plasma concentration (Cmax) of SP2086.	At protocol-specified times up to Day 4 and Day 18.	Cmax (a measure of the body's exposure to SP2086) will be compared. before and after administration of multiple doses of SHR3824
The area under the plasma concentration-time curve (AUC) of SP2086.	At protocol-specified times up to Day 4 and Day 18.	AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SHR3824.
The number of volunteers with adverse events as a measure of safety and tolerability.	Up tp day 18.

Trial Locations

Locations (1)

Phase I Unit of Tongji Hospital affilated Tongji Medical School of Huangzhong Science and Thechnology; 🇨🇳 Wuhan, Hubei, China