← Trials/Trial dossier/NCT02451527
The Pharmacokinetic Study of the Combination of Digoxin and Polythylene Glycol Loxenatide Injection in Healthy Subjects
An Open-label,Single-arm,Sequential,Single-center Clinical Trial of the Pharmacokinetic Study of the Combination of Digoxin and Polythylene Glycol Loxenatide Injection (PEX168) in Healthy Adult Subjects
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 19-25•Male•Healthy volunteers
Primary endpoint
•Composite of pharmacokinetic (PK) parameters 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 males aged from 18 to 45 years
2. Have a body weight over 50kg, have a body mass index (BMI) 19-25 kg/m^2 (both inclusive)
3. Alanine aminotransferase<50 U/L, aspartate aminotransferase<50 U/L, alkaline phosphatase and total bilirubin <1.5x the upper limit of normal
4. According to Cockcroft-Gault, estimated Clcr≥90ml/min
5. Able to comprehend and willing to sign the informed consent form
Exclusion criteria
1. Hepatitis B surface antigen(+), Hepatitis C virus antibody(+),AIDS antibody(+)
2. History of syncope, palpitations, bradycardia and tachycardia (for example any degree of atrioventricular block, left bundle branch block, right bundle branch block), or have an abnormal result of overall physical examination (vital signs, physical examination), routine laboratory assessment (hematology, biochemistry and urinalysis), 12-lead ECG and abdominal sonography (liver, gallbladder, pancreas, spleen, kidney)
3. Have had an alcohol and substance abuse within 6 months of screening
4. History of smoking within 3 months of screening
5. BP>140/90 millimetres of mercury, or heart rate >100 bpm
6. QT interval >450ms
7. History of drug-induced allergy or of hypersensitivity for digoxin and PEX168
8. History of serious heart disease or lung disease
9. Fasting triglyceride>1.5x the upper limit of normal
10. Subjects with liver disease or have history of liver disease or abnormal liver and gallbladder conditions
11. Donation of blood in excess of 400 mL within the 3 months of screening; or donation of blood within 1 month of screening; or received blood transfusions within 1 month of screening.
12. Hypothyroidism
13. Surgery of gastrointestinal tract
14. History of pancreatitis
15. History of cholecystitis or other gallbladder disease
16. History of inflammatory bowel disease or irritable bowel syndrome
17. History of MEN type 2 syndrome
18. History of medullary thyroid carcinoma
19. A family history of MEN type 2 syndrome and medullary thyroid carcinoma
20. Have participated in clinical trials with drug or medical devices involved within 3 months of screening
21. Have received any drug that may affect the study drugs within 2 weeks of screening, including prescribed drugs, over-counted drugs, Chinese traditional medicine or multivitamins
22. History of grapefruit juice, cranberry, mango, foods and drinks of xanthine or caffeine, strenuous exercise, or any other factor affect the absorption, distribution, metabolism and excretion of the study drug within 2 days of screening
23. Have received any glucagon-like peptide-1 mimetic compound(e.g., exenatide)
24. Have been disagreed to use a reliable method of birth control during the study and for 6 months following the last dose of study drug
25. History of any other condition, which in the opinion of the investigator, may prevent the subject from following and completing the protocol
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 of pharmacokinetic (PK) parameters of digoxin with and without PEX168 in plasma and urine (cmax, t 1/2)
Time frame:Day 1 through Day 44
concentration, descriptive
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame:Day 1 through Day 44
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.