The Metabolite Identification and Material Balance Study of SP2086

Phase 1

Completed

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

• Registration Number: NCT02815748
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

The purpose of the study is to investigate the Metabolite identification and material balance of SP2086 in healthy adult volunteers.

Detailed Description

All subjects were given SP2086 100mg only one time, and blood sample should be collected before and 96 hours after medicine taken.

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2016-01-03
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-28
• Last Update Submitted: 2016-06-29
• Last Update Posted: 2016-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Healthy volunteers with a body mass index(BMI) between 19 and 25 Kg/m2,and weight ≥50kg.
• Lab and other examination results were normal or mildly abnormal without clinical significance, clinical doctors had considered eligible.
• Had signed the informed consent himself or herself voluntarily.

Exclusion Criteria

• Has a history of severe system disease, or family history (including the cardiovascular system, digestive system, urinary system, etc.).
• Has a history of allergy or intolerance to SP2086 OR other DPP-IV.
• The subjects participated 3 times or more than 3 times drug clinical subjects in nearly a year;participate any drug clinical trial prior to the test 3 months, or had blood donor, or plan to blood donors three months before the test;or had a transfusion in 4 weeks.
• Did not take effective contraceptive measures or planning of the subjects in half a year.
• Researchers considered the patient adherence is poor, or has any unfavorable factors that not suit to participate the test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SP2086	SP2086	SP2086 was taken only one time at 100mg dose in health volunteers

Primary Outcome Measures

Name	Time	Method
The maximum plasma concentration (Cmax) of SP2086 acid	up to 96 hours	Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086
The maximum plasma concentration (Cmax) of SP2086	up to 96 hours	Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086
The area under the plasma concentration-time curve (AUC) of SP2086 acid	up to 96 hours	AUC (a measure of the body's exposure to SP2086 acid) 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 96 hours	AUC (a measure of the body's exposure to SP2086) 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 96 hours