Type 2 Diabetes MellitusPhase 1NCT02467790
Polyethylene Glycol Loxenatide Pharmacokinetics Study in Subjects With Normal and Insufficiency Renal Function
A Phase 1 study testing PEX168 in people with Type 2 Diabetes Mellitus, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 31 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- PEX168
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
- Researchers believe any situation that might lead to any subject can not be completed or to the subject of this study bring significant risk.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Xiangya Hospital, Central South Univety
Changsha, Hunan
Hao Zhang, MD, 13975806919, zhanghaoliaoqin@163.com
Guoping Yang, MD, 13974817168, ygp9880@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- PEX168
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEX168Drug
Also called Polyethylene Glycol Loxenatide
PEX 168: 200µg,Subcutaneous,one time.
| Study group | Role | What they receive |
|---|---|---|
| Mild renal insufficiency | Experimental | PEX 168: 200µg,Subcutaneous,one time. Receives: Drug: PEX168 |
| Moderate renal insufficiency | Experimental | PEX 168: 200µg,Subcutaneous,one time. Receives: Drug: PEX168 |
| Normal renal function | Experimental | PEX 168: 200µg,Subcutaneous,one time. Receives: Drug: PEX168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day31
Secondary outcomes (1)
Incidence of adverse events and serious adverse events
Measured: Baseline to Day31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guoping Yang, MD, Principal investigator, The Third Xiangya Hospital,Center South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467790
- Sponsor's protocol ID
- PEX168-Ih
- Status last verified
- Jan 2016
- First submitted
- 8 Jun 2015
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31396983
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetic Study of Human Pharmacokinetics in Normal Renal Function, and Renal Insufficiency Subject of Polyethylene Glycol Loxenatide (PEX168)(Open, Non-randomized, Parallel-group)
- ClinicalTrials.gov ID
- NCT02467790
- Acronym / sponsor ID
- PEX168-Ih
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild renal insufficiency | Experimental | Drug: PEX168PEX 168: 200µg,Subcutaneous,one time. |
| Moderate renal insufficiency | Experimental | Drug: PEX168PEX 168: 200µg,Subcutaneous,one time. |
| Normal renal function | Experimental | Drug: PEX168PEX 168: 200µg,Subcutaneous,one time. |
Who may qualify
- Ages
- 31 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEX168Also: Polyethylene Glycol LoxenatidePEX 168: 200µg,Subcutaneous,one time. | Drug | Mild renal insufficiency, Moderate renal insufficiency, Normal renal function |
Primary outcome
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.
1 secondary outcome
Incidence of adverse events and serious adverse events
Time frame: Baseline to Day31
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Derived from this study: PubMed 31396983Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoping Yang, MD principal investigator
The Third Xiangya Hospital,Center South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEX168 in people with Type 2 Diabetes Mellitus, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Zhang, MD (13975806919, zhanghaoliaoqin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic index (time frame: Baseline to Day31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02467790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.