The Pharmacokinetic Study of the Combination of Digoxin and Polythylene Glycol Loxenatide Injection in Healthy Subjects

NCT02451527 | Completed Phase 1 DMC

• 1 other identifier: 2013L02060
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Day 1 through Day 44

Study Arms (1)

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.

Drug: Digoxin; Drug: PEX168

Interventions

Digoxin DRUG

Digoxin 0.5mg tablet by mouth on Day 1 and Day 38

Also known as: Digoxine, Digoxinum, Lanoxin, Vanoxin

Digoxin and PEX168

PEX168 DRUG

PEX168 in subcutaneous injection on Day8，15，22，29 and Day 36

Also known as: Polythylene Glycol Loxenatide Injection

Digoxin and PEX168

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males aged from 18 to 45 years
• Have a body weight over 50kg, have a body mass index (BMI) 19-25 kg/m\^2 (both inclusive)
• Alanine aminotransferase\<50 U/L, aspartate aminotransferase\<50 U/L, alkaline phosphatase and total bilirubin \<1.5x the upper limit of normal
• According to Cockcroft-Gault, estimated Clcr≥90ml/min
• Able to comprehend and willing to sign the informed consent form

You may not qualify if:

• Hepatitis B surface antigen(+)， Hepatitis C virus antibody(+)，AIDS antibody（+）
• 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)
• Have had an alcohol and substance abuse within 6 months of screening
• History of smoking within 3 months of screening
• BP\>140/90 millimetres of mercury, or heart rate \>100 bpm
• QT interval \>450ms
• History of drug-induced allergy or of hypersensitivity for digoxin and PEX168
• History of serious heart disease or lung disease
• Fasting triglyceride\>1.5x the upper limit of normal
• Subjects with liver disease or have history of liver disease or abnormal liver and gallbladder conditions
• 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.
• Hypothyroidism
• Surgery of gastrointestinal tract
• History of pancreatitis
• History of cholecystitis or other gallbladder disease

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Interventions

Digoxin; polyethylene glycol loxenatide

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Bingyin Shi, MD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 22, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: July 1, 2016
• Last Updated: November 30, 2016

Record last verified: 2016-08

Locations

CN (1)