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

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: SP2086

Study type: Interventional

Funder types: Industry

Identifiers

NCT02826044

SP2086-114

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

SP2086 50mg

Experimental group

Description:

there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 10 healthy volunteers.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.

Treatment:

Drug: SP2086

SP2086 100mg

Experimental group

Description:

there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 10 healthy volunteers.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.

Treatment:

Drug: SP2086

SP2086 200mg

Experimental group

Description:

there were 3 groups in the study: 50mg ,100mg and 200mg ,each group including 10 healthy volunteers.All subjects were administrated the medicine at Day 1 and Day 5 to Day 9.During the test,collecting the blood samples were needed before and after taking medicine.

Treatment:

Drug: SP2086