The Metabolite Identification and Material Balance Study of SP2086

Type 2 Diabetes Clinical Trial

Official title:

A Single-center, Randomized, Open, Single Dose Phase I Study to Access the Metabolite Identification and Material Balance in Health Volunteer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815748
• Other study ID #: HR-SP2086-109
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2016
• Last updated: June 29, 2016
• Start date: August 2015
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• SP2086
SP2086 was taken only one time at 100mg dose in health volunteers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 96 hours	No
Primary	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 96 hours	No
Primary	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 96 hours	No
Primary	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 96 hours	No
Secondary	The number of volunteers with adverse events as a measure of safety and tolerability		up to 96 hours	Yes