Polyethylene Glycol Loxenatide Pharmacokinetics Study in Subjects With Normal and Insufficiency Renal Function

January 23, 2016 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Kinetic Study of Human Pharmacokinetics in Normal Renal Function, and Renal Insufficiency Subject of Polyethylene Glycol Loxenatide (PEX168)(Open, Non-randomized, Parallel-group)

To compare and analysis pharmacokinetics of PEX 168 in patients with renal insufficiency or normal renal function who were administrated subcutaneously single dose PEX168.To evaluate dose adjustment of PEX168 administered in patients with renal insufficiency and provide a scientific basis in patients with renal insufficiency of rational drug use.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is an open, non-randomized, parallel-group, single-dose study that evaluated the pharmacokinetics of PEX168 when single dose administered with PEX168 in patients with renal insufficiency and normal renal function subjects. The total duration of each subject's participation in the study was approximately 45 days, which included up to a 14-day Screening Period, a 31-day PK sample collecting Period.

Center: This study was conducted at two sites in the Third Xiangya hospital of Center South University and Shanghai Changhai Hospital.All subjects receives a single 200μg doses of PEX168 injected subcutaneously on Day 1.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Chang Sha, Hunan, China
        • Recruiting
        • Third Xiangya Hospital, Central South Univety
        • Contact:
        • Contact:

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

31 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 31-65 (both inclusive) years old, male or female;
  2. Weight: Male ≥50kg, female ≥45kg, 18≤BMI≤28;
  3. The Cockcroft-Gault (CG) formula to estimate creatinine clearance (CLCr), K / DOQI definition of chronic kidney disease (CKD) 2 patients: 60≤CLcr≤89 ml / min; chronic kidney disease (CKD) 3 patients: 30≤CLcr≤59 ml / min for renal insufficiency,Cockcroft-Gault (CG) formula to estimate creatinine clearance (CLCr) ≥90ml / min for normal subjects.
  4. In the 48 hours before the start of the test to the end of the trial period, agreed to get rid of tobacco, alcohol, caffeine, fruit juice subject;
  5. Understand the study procedures and methods, voluntarily participate in this experiment, and writing and signed informed consent.

Exclusion Criteria:

  1. Known or suspected of GLP-1 class of drug allergy or allergy;
  2. Before screening,received GLP-1 receptor agonists, GLP-1 analogs, DPP-IV inhibitors or any other similar structure of the drug treatment;
  3. In addition to the induced renal dysfunction disease itself, suffering from any other organ of acute illness and those with any influence of drugs in vivo study of chronic diseases;
  4. within 6 months prior to screening,having any surgery, including the impact of gastric emptying of gastrointestinal surgery;
  5. Screened within the previous three months to participate in blood donation and blood donation ≥400mL, or who participate in blood donation or blood transfusion within one month;
  6. Within 3 months before screening participated in any drug or medical device trials are (including placebo);
  7. Drinking, smoking addiction, drug abuse and drug abusers;
  8. In addition to judging laboratory abnormalities diagnosis of renal dysfunction caused by disease, there are other clinically significant laboratory abnormalities (Note: Patients with moderate to severe anemia (Hb <60g / L), severe hypertension ( SBP> 160mmHg and / or diastolic blood pressure> 100mmHg) patients, heart rate> 100bmp, ECG QTc> 450ms were required to exclude;
  9. ALT> 1.5 times the upper limit of normal and / or aspartate transaminase> 1.5 times the upper limit of normal and / or total bilirubin> 1.5 times the upper limit of normal;
  10. Fasting triglycerides> 5.64mmol / L (500mg / dl);
  11. Beyond the normal range of serum amylase, and the clinical significance is determined by the investigator;
  12. Pancreatitis, pancreatic cancer a history;
  13. Blood thyroid stimulating hormone (TSH) beyond the normal range and clinically significant judgment by the investigator;
  14. The pregnancy test was positive women of childbearing age, or pregnant women, breastfeeding women, and within six months there have been unwilling or unable to take family planning and effective contraception during the trial of male / female volunteers;
  15. The hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test positive;
  16. Researchers believe any situation that might lead to any subject can not be completed or to the subject of this study bring significant risk.

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mild renal insufficiency
PEX 168: 200µg,Subcutaneous,one time.
Drug: PEX168
PEX 168: 200µg,Subcutaneous,one time.
Other Names:
  • Polyethylene Glycol Loxenatide
EXPERIMENTAL: Moderate renal insufficiency
PEX 168: 200µg,Subcutaneous,one time.
Drug: PEX168
PEX 168: 200µg,Subcutaneous,one time.
Other Names:
  • Polyethylene Glycol Loxenatide
EXPERIMENTAL: Normal renal function
PEX 168: 200µg,Subcutaneous,one time.
Drug: PEX168
PEX 168: 200µg,Subcutaneous,one time.
Other Names:
  • Polyethylene Glycol Loxenatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic index
Time Frame: Baseline to Day31
Prior to administration (within 60 minutes, recorded as 0h) and after administration 24h (Day 2), 48h (Day 3), 72h (day 4), 96h (day 5), 120h (day 6 ), 144h (day 7), 216h (day 10), 312h (day 14 ), 480h (day 21), 648h (day 28), 720h (day 31) collect blood 3 ml and test serum concentrations of PEX168.
Baseline to Day31

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and serious adverse events
Time Frame: Baseline to Day31
Baseline to Day31

Collaborators and Investigators

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

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Guoping Yang, MD, The Third Xiangya Hospital,Center South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2015

Primary Completion (ANTICIPATED)

March 1, 2016

Study Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (ESTIMATE)

June 10, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 23, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEX168-Ih

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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