NCT02467790

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2015

Longer than P75 for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

June 8, 2015

Last Update Submit

January 23, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic index

    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 Outcomes (1)

  • Incidence of adverse events and serious adverse events

    Baseline to Day31

Study Arms (3)

Mild renal insufficiency

EXPERIMENTAL

PEX 168: 200µg,Subcutaneous,one time.

Drug: PEX168

Moderate renal insufficiency

EXPERIMENTAL

PEX 168: 200µg,Subcutaneous,one time.

Drug: PEX168

Normal renal function

EXPERIMENTAL

PEX 168: 200µg,Subcutaneous,one time.

Drug: PEX168

Interventions

PEX168DRUG

PEX 168: 200µg,Subcutaneous,one time.

Also known as: Polyethylene Glycol Loxenatide
Mild renal insufficiencyModerate renal insufficiencyNormal renal function

Eligibility Criteria

Age31 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 31-65 (both inclusive) years old, male or female;
  • Weight: Male ≥50kg, female ≥45kg, 18≤BMI≤28;
  • 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.
  • 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;
  • Understand the study procedures and methods, voluntarily participate in this experiment, and writing and signed informed consent.

You may not qualify if:

  • Known or suspected of GLP-1 class of drug allergy or allergy;
  • Before screening,received GLP-1 receptor agonists, GLP-1 analogs, DPP-IV inhibitors or any other similar structure of the drug treatment;
  • 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;
  • within 6 months prior to screening,having any surgery, including the impact of gastric emptying of gastrointestinal surgery;
  • 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;
  • Within 3 months before screening participated in any drug or medical device trials are (including placebo);
  • Drinking, smoking addiction, drug abuse and drug abusers;
  • 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;
  • 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;
  • Fasting triglycerides\> 5.64mmol / L (500mg / dl);
  • Beyond the normal range of serum amylase, and the clinical significance is determined by the investigator;
  • Pancreatitis, pancreatic cancer a history;
  • Blood thyroid stimulating hormone (TSH) beyond the normal range and clinically significant judgment by the investigator;
  • 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;
  • The hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test positive;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Xiangya Hospital, Central South Univety

Changsha, Hunan, China

RECRUITING

Related Publications (1)

  • Wang J, Huang J, Li W, Tang S, Sun J, Zhang X, Liu J, Yi B, Liu J, Zhang X, Yang Q, Yang X, Yang S, Yang G, Zhang H. Polyethylene glycol loxenatide (PEX168) in subjects with renal impairment: A pharmacokinetic study. Br J Clin Pharmacol. 2019 Dec;85(12):2714-2720. doi: 10.1111/bcp.14091. Epub 2019 Dec 8.

    PMID: 31396983DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

polyethylene glycol loxenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Guoping Yang, MD

    The Third Xiangya Hospital,Center South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Zhang, MD

CONTACT

13975806919zhanghaoliaoqin@163.com

Guoping Yang, MD

CONTACT

13974817168ygp9880@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 10, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

CN(1)