The Metabolite Identification and Material Balance Study of SP2086

June 29, 2016 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: SP2086
SP2086 was taken only one time at 100mg dose in health volunteers
Drug: SP2086
SP2086 was taken only one time at 100mg dose in health volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The maximum plasma concentration (Cmax) of SP2086
Time Frame: 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
up to 96 hours
The maximum plasma concentration (Cmax) of SP2086 acid
Time Frame: 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
up to 96 hours
The area under the plasma concentration-time curve (AUC) of SP2086
Time Frame: 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
up to 96 hours
The area under the plasma concentration-time curve (AUC) of SP2086 acid
Time Frame: 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
up to 96 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of volunteers with adverse events as a measure of safety and tolerability
Time Frame: up to 96 hours
up to 96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: XingHe Wang, P.H.D, Beijing Shijitan Hospital Affiliated to Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 3, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Estimate)

July 1, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HR-SP2086-109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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