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Status unknownNCT02826044Updated Jul 7, 2016

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

A Phase 1 interventional study of SP2086 in Type 2 Diabetes, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-07.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    SP2086 50mg

    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.

    Drug: SP2086

  • Experimental
    SP2086 100mg

    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.

    Drug: SP2086

  • Experimental
    SP2086 200mg

    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.

    Drug: SP2086

Interventions

  • DrugSP2086

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to Day 13

  2. 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

    Time frame: up to Day 13

  3. 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.

    Time frame: up to Day 13

  4. 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

    Time frame: up to Day 13

  5. 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

    Time frame: up to Day 13

  6. 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

    Time frame: up to Day 13

  7. 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

    Time frame: up to Day 13

  8. 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

    Time frame: up to Day 13

  9. Cumulative excretion of SP2086

    Time frame: up to Day 13

Secondary outcomes

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

    Time frame: up to Day 13

07

Study locations

1 site
  • the First Hosital of Jilin University
    Changchun, Jilin, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02826044
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jul 7, 2016
Start date
Jul 2016
Primary completion
Sep 2016 (estimated)
Last update
Jul 7, 2016

Study contacts

Yanhua Ding, docter
Contact
dingyanhua2003@126.com
0431-88782168

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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