The Metabolite Identification and Material Balance Study of SP2086

NCT02815748 | Completed Phase 1

• 1 other identifier: HR-SP2086-109
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 2 Diabetes

Keywords

SP2086; Metabolite identification; Material balance

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• The number of volunteers with adverse events as a measure of safety and tolerability

  up to 96 hours

Study Arms (1)

SP2086

OTHER

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

Drug: SP2086

Interventions

SP2086 DRUG

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

SP2086

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• XingHe Wang, P.H.D

  Beijing Shijitan Hospital Affiliated to Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2016
• First Posted: June 28, 2016
• Study Start: August 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 1, 2016

Record last verified: 2016-06