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

NCT02461914 | Completed Phase 1 DMC

• 1 other identifier: PEX168-Ii
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the effect of PEX168 doses on the pharmacokinetics of warfarin in healthy subjects.To provide a scientific basis for clinical drug combination of PEX168. To evaluated the impact of pharmacodynamics coadministrated hypodermic PEX168 and warfarin in healthy subjects. To assess the safety of single doses of warfarin administered with and without PEX168

Conditions

Healthy

Keywords

Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Composite measure the plasma concentrations of warfarin

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

  Baseline to Day51

Secondary Outcomes (1)

• Incidence of adverse events and serious adverse events

  Baseline to Day78

Study Arms (1)

Warfaring and PEX168(200µg)

EXPERIMENTAL

Warfarin: 5mg, oral Administration. PEX 168: 200µg,injected subcutaneously,once a week.

Drug: PEX168; Drug: Warfarin

Interventions

PEX168 DRUG

200µg,injected subcutaneously,once a week.

Also known as: Polyethylene Glycol Loxenatide

Warfaring and PEX168(200µg)

Warfarin DRUG

5mg,oral,two times.

Also known as: Warfarin sodium tablets

Warfaring 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, or via a comprehensive physical examination , routine laboratory tests (blood count, blood biochemistry, urine, etc.), 12-lead ECG, abdominal B ultrasound, 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:
• \) Warfarin and / or any of its ingredients or other similar drugs . 2) PEX168
• \. Before screening, having a history of cardiovascular disease or a history of pulmonary disease ;
• \. The history of thromboembolic disease or undergoing surgery or gastrointestinal bleeding within 6 months before screening, or excessive bleeding or a history of heparin-induced thrombocytopenia have significant bleeding history or family history;
• In screening period,platelet count or international normalized ratio (INR) or activated partial thromboplastin time (APTT) greater than the upper limit of the normal range or fibrinogen is less than the lower limit of the normal range;
• \. 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;
• \. In screening period, having thyroid dysfunction or a history;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

polyethylene glycol loxenatide; Warfarin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jianzhong Shentu, MD

  The first affiliate of Zhejiang 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 3, 2015
• Study Start: August 1, 2015
• Primary Completion: December 12, 2015
• Study Completion: July 13, 2016
• Last Updated: January 24, 2017

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share