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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2016
• Main ID: NCT02467790
• Date of registration: 08/06/2015
• Prospective Registration: No
• Primary sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Public title: Polyethylene Glycol Loxenatide Pharmacokinetics Study in Subjects With Normal and Insufficiency Renal Function
• Scientific title: Kinetic Study of Human Pharmacokinetics in Normal Renal Function, and Renal Insufficiency Subject of Polyethylene Glycol Loxenatide (PEX168)(Open, Non-randomized, Parallel-group)
• Date of first enrolment: February 2015
• Target sample size: 24
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02467790
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Hao Zhang, MD

• Name: Hao Zhang, MD

• Name: Guoping Yang, MD
• Affiliation: The Third Xiangya Hospital,Center South University

Key inclusion & exclusion criteria

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.



Age minimum: 31 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: PEX168

Primary Outcome(s)

Pharmacokinetic index [Time Frame: Baseline to Day31]

Secondary Outcome(s)

Incidence of adverse events and serious adverse events [Time Frame: Baseline to Day31]

Secondary ID(s)

PEX168-Ih

Source(s) of Monetary Support

Please refer to primary and secondary sponsors