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Evaluate the Pharmacokinetics of Digoxin When Coadministered With PEX168 in Healthy Adult Subjects
An Open-label,Sequential,Single-site Study to Evaluate the Pharmacokinetics of Digoxin When Coadministered With Polyethylene Glycol Loxenatide (PEX168) in Healthy Adult Subjects
Lead sponsor
Asset
Loxenatide / PEG-loxenatide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
16
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI 18-25•Male•Healthy volunteers
Primary endpoint
•Composite measure the plasma concentrations of Digoxin
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Healthy male aged 18 to 45 years (including both ends) at the time of signing the informed consent.
2. Weighing not less than 50kg,Body Mass Index (BMI)of 18 to 25kg/m2.
3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (Tbil) are within the normal range during screening;
4. Estimated creatinine clearance (Clcr) ≥90ml / min calculated by the Cockcroft-Gault (CG) formula ;
5. Capable of giving written informed consent, which included compliance with the requirements and restrictions listed in the consent form.
Exclusion criteria
1. The hepatitis B surface antigen, hepatitis C antibody, HIV antibody test positive;
2. Having history of syncope, palpitations, bradycardia, tachycardia and other anomalies(such as the extent of any way block, left bundle branch block, right bundle branch block), or via a comprehensive physical examination (vital signs, physical examination), routine laboratory tests (blood count, blood biochemistry, urine, etc.), 12-lead ECG, abdominal B ultrasound (liver, gallbladder, pancreas, spleen, kidney), and other abnormalities and clinical significance persons before screening;
3. Having Alcohol and drug abuse within first 6 months before screening;
4. Smoked within 3 months before screening;
5. In screening period, blood pressure greater than 140 / 90mmHg, retest after diagnosis or pulse rate is higher than 100bpm person;
6. In screening period, ECG QTc> 450ms,diagnosed after retest;
7. Having a history of drug or allergic reactions or allergic constitution have hypersensitivity to any of the following:
1) digoxin and / or any of its ingredients or other similar drugs . 2) PEX168
8. Before screening, having a history of cardiovascular disease (coronary heart disease, high blood pressure, high cholesterol, etc.) or a history of pulmonary disease (chronic bronchitis, emphysema, asthma, pneumonia, etc.);
9. In screening period , fasting triglycerides test result was greater than the upper limit of normal range;
10. Currently there is a history of liver disease or liver disease or a known hepatobiliary abnormalities (except asymptomatic gallstones);
11. Participate in blood donation and donation amount ≥400ml within three months before screening, or who participate in blood donation or blood transfusion within a month;
12. In screening period, having thyroid dysfunction or a history;
13. The history of gastrointestinal surgery (such as stomach cutting surgery, gastric bypass surgery) before screening;
14. The history of pancreatitis;
15. History of cholecystitis gallbladder disease or other disease history;
16. The history of inflammatory bowel disease or a history of irritable bowel syndrome;
17. The history of Type 2 multiple endocrine neoplasia;
18. The history of medullary thyroid cancer;
19. The family has type 2 multiple endocrine fibromatosis or a history of medullary thyroid cancer;
20. 3 months before screening, participating in any drug or medical device trials are (including placebo);
21. Using any of the tested drugs may affect prescription drugs , non-prescription drugs, herbal (especially ginseng, oral hypoglycemic agents) or multivitamin supplements persons;
22. Drinking medication or caffeine-containing xanthine food and beverage (listed in annex 3), strenuous exercise, or other effects of drug absorption, distribution, metabolism, excretion and other factors 2 days before screening.
23. Received GLP-1 analogs (e.g. exenatide) treatment;
24. Reluctant to take an effective method of contraception during the test, fertility planner within six months after his or her spouse during the test or the last dose (38 days);
25. Researchers believe any situation that might lead to any subject cannot complete the study or to the subject of this study bring significant risk.
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
2 endpointsComposite measure the plasma concentrations of Digoxin.
Time frame:Baseline to Day44
concentration, descriptive
Incidence of adverse events and serious adverse events
Time frame:Baseline to Day72
event count, event
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.