The Pharmacokinetics Study of Single and Multiple Dose of SP2086 in Healthy Volunteers

Type 2 Diabetes Clinical Trial

Official title:

Pharmacokinetics,Safety and Tolerability Study Following Single and Multiple Dose of SP2086 in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02826044
• Other study ID #: SP2086-114
• Status: Not yet recruiting
• Phase: Phase 1
• First received: July 4, 2016
• Last updated: July 4, 2016
• Start date: July 2016

Study information

• Verified date: April 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Yanhua Ding, docter
• Phone: 0431-88782168
• Email: dingyanhua2003[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

SP2086 is a novel inhibitor of Dipeptide base peptidase 4, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose and multiple-dose study the investigators evaluated the safety, tolerability and Pharmacokinetics profiles of SP2086 in healthy volunteers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• BMI(a measure of a person's weight in relation to height)is between 19 and 26 kg/m2,and the weight is equal or less than 100kg.

• without the history of cardiovascular diseases,liver diseases,kidney diseases,gastrointestinal tract diseases,mental nerve diseases and drug allergy.

• Be willing to accept physical contraception.

• Sign the informed consents voluntarily and ensure to completed the study.

Exclusion Criteria:

• Known allergy to SP2086 or any of the excipients of the formulation of SP2086;

• ever occured myocardial infarction,acute coronary syndrome, transient ischemic attack.

• the B hepatitis surface antigen or hepatitis C antibody or syphilis antibody or HIV antibody was positive.

• had participated three or more clinical trial in one year or had participated one time clinical medicine in one month of screening.

• have the history of blood donation in 3 months of screening or received the blood transfusion in 1 months of screening.

• have the history of tobacco,alcohol or drug abuse.

• History of or current clinically significant medical illness as determined by the Investigator.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• SP2086
The study has 3 doses groups and the 30 subjects were administrated SP2086 50mg,100mg,200mg respectively.

Locations

Country	Name	City	State
China	the First Hosital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

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 a single dose of SP2086.	up to Day 13	No
Primary	The steady-state plasma concentration (Css) of SP2086	Css (a measure of the body's exposure to SP2086) will be compared before and after administration of multiple doses of SP2086	up to Day 13	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 a single dose of SP2086.	up to Day 13	No
Primary	The steady-state plasma concentration (Css) of SP2086 acid	Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086	up to Day 13	No
Primary	The maximum urine 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 SP2086	up to Day 13	No
Primary	The steady-state urine concentration (Css) of SP2086	Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086	up to Day 13	No
Primary	The maximum urine 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 SP2086	up to Day 13	No
Primary	The steady-state urine concentration (Css) of SP2086 acid	Css (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of multiple doses of SP2086	up to Day 13	No
Primary	Cumulative excretion of SP2086		up to Day 13	No
Secondary	The number of volunteers with adverse events as a measure of safety and tolerability		up to Day 13	Yes