Evaluate the Pharmacokinetics of Digoxin When Coadministered With PEX168 in Healthy Adult Subjects

NCT02472236 | Completed Phase 1 DMC

• 1 other identifier: PEX168-Ij
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effect of PEX168 doses on the pharmacokinetics of digoxin in healthy subjects.To provide a scientific basis for clinical drug combination of PEX168. To assess the safety of single doses of digoxin administered with and without PEX168

Conditions

Healthy

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Composite measure the plasma concentrations of Digoxin.

  Plasma concentrations of digoxin, and to calculate the pharmacokinetic parameters: Tmax、Cmax、AUC0-t、AUC0-∞、λz ，t1/2、Vd/F、CLr etc.

  Baseline to Day44

Secondary Outcomes (1)

• Incidence of adverse events and serious adverse events

  Baseline to Day72

Study Arms (1)

Digoxin and PEX168(200µg)

EXPERIMENTAL

Digoxin: 0.5mg, oral Administration. PEX 168: 200µg,injected subcutaneously,once a week.

Drug: PEX168; Drug: Digoxin

Interventions

PEX168 DRUG

200µg,injected subcutaneously,once a week.

Also known as: Polyethylene Glycol Loxenatide

Digoxin and PEX168(200µg)

Digoxin DRUG

0.5mg,oral,two times.

Also known as: Digaoxin tablet

Digoxin and PEX168(200µg)

Eligibility Criteria

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

You may qualify if:

• Healthy male aged 18 to 45 years (including both ends) at the time of signing the informed consent.
• Weighing not less than 50kg，Body Mass Index (BMI)of 18 to 25kg/m2.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin (Tbil) are within the normal range during screening;
• Estimated creatinine clearance (Clcr) ≥90ml / min calculated by the Cockcroft-Gault (CG) formula ;
• Capable of giving written informed consent, which included compliance with the requirements and restrictions listed in the consent form.

You may not qualify if:

• The hepatitis B surface antigen, hepatitis C antibody, HIV antibody test positive;
• 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;
• Having Alcohol and drug abuse within first 6 months before screening;
• Smoked within 3 months before screening;
• In screening period, blood pressure greater than 140 / 90mmHg, retest after diagnosis or pulse rate is higher than 100bpm person;
• In screening period, ECG QTc\> 450ms,diagnosed after retest;
• Having a history of drug or allergic reactions or allergic constitution have hypersensitivity to any of the following:
• \) digoxin and / or any of its ingredients or other similar drugs . 2) PEX168
• \. 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.);
• \. In screening period , fasting triglycerides test result was greater than the upper limit of normal range;
• \. Currently there is a history of liver disease or liver disease or a known hepatobiliary abnormalities (except asymptomatic gallstones);
• \. 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;
• \. In screening period, having thyroid dysfunction or a history;
• \. The history of gastrointestinal surgery (such as stomach cutting surgery, gastric bypass surgery) before screening;
• \. The history of pancreatitis;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The first affiliate of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

polyethylene glycol loxenatide; Digoxin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bingyin Shi

  The first affiliate of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 15, 2015
• Study Start: June 8, 2015
• Primary Completion: September 24, 2015
• Study Completion: January 18, 2016
• Last Updated: January 24, 2017

Record last verified: 2016-01

Locations

CN (1)