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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild renal insufficiency | Experimental | PEX 168: 200µg,Subcutaneous,one time. |
|
| Moderate renal insufficiency | Experimental | PEX 168: 200µg,Subcutaneous,one time. |
|
| Normal renal function | Experimental | PEX 168: 200µg,Subcutaneous,one time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEX168 | Drug | PEX 168: 200µg,Subcutaneous,one time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and serious adverse events | Baseline to Day31 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Zhang, MD | Contact | 13975806919 | zhanghaoliaoqin@163.com | |
| Guoping Yang, MD | Contact | 13974817168 | ygp9880@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guoping Yang, MD | The Third Xiangya Hospital,Center South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Xiangya Hospital, Central South Univety | Recruiting | Changsha | Hunan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31396983 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000601947 | polyethylene glycol loxenatide |
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| D004700 | Endocrine System Diseases |