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The purpose of this study is to evaluate the pharmacokinetic study of the combination of digoxin and polythylene glycol loxenatide injection (PEX168) in healthy adults,and to provide scientific basis for clinical combination of PEX168 and drugs.This study is also to evaluate the safety and tolerability of mono-digoxin or digoxin plus PEX168.
This will be an open-label, single-arm, sequential, single-center clinical trial. 16 healthy males will be admitted to the clinical facility on Day -1, the day prior to the start of dosing. The subjects will be observed in clinic twice: Day -1 to 8 and Day 37 to 44. Subjects will receive a single dose of digoxin on Day 1 followed by 5 weekly subcutaneously injected doses of PEX168 and a second single dose of digoxin on Day 38. To determine the pharmacokinetic parameters of digoxin after drug administration alone and after multiple doses of PEX168, blood and urine samples will be collected after each dose of digoxin and tested by the laboratory.The subjects will be discharged on Day 8 and Day 44. Approximately 28 days after the last discharge, the subjects will be called for a post study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digoxin and PEX168 | Experimental | A single dose of 0.5mg digoxin administered on Day 1 followed by 5 weekly subcutaneous injections of a single dose of 200ug PEX168, followed by a further single dose of 0.5mg digoxin on Day 38. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug | Digoxin 0.5mg tablet by mouth on Day 1 and Day 38 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic (PK) parameters of digoxin with and without PEX168 in plasma and urine (cmax, t 1/2) | Maximum observed concentration in plasma(cmax); apparent terminal elimination half-life in plasma(t1/2). | Day 1 through Day 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Day 1 through Day 44 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bingyin Shi, MD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| C000601947 | polyethylene glycol loxenatide |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| PEX168 | Drug | PEX168 in subcutaneous injection on Day8,15,22,29 and Day 36 |
|
|
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |