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Completed

NCT Number: NCT02815748

The Metabolite Identification and Material Balance Study of SP2086

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SP2086

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

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

    Time frame: up to 96 hours

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 28, 2016
Registry last updated
Jul 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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