Back to resultsPharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Imrecoxib
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
All subjects:
- Between the ages of 18 to 70 years, with BMI 18~ 29kg/m2.
- In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory test values(except for values related to hepatic insufficiency).
Hepatic impaired subjects:
- Hepatocirrhosis subjects verified by B-mode ultrasonography,CT ,MRI or Biopsy.
- A Child-Pugh Classification score clinically determined as Class B.
Exclusion Criteria:
All subjects:
- History of hypersensitivity to Imrecoxib or its components.
Subjects diagnosed with tumor.
- History of or current clinically important systemic illnesses, including but not limited to cardiovascular, pulmonary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological, or psychiatric diseases.
- Have used any drugs or substances (including herbal supplements) known to inhibit or induce cytochrome P450 enzymes including cytochrome P450 3A4, cytochrome P450 2C8 and cytochrome P450 2C9 within 28 days prior to the first dose and throughout the study.
- Have taken other investigational drugs or participated in any clinical trial within 90 days prior to first dose of study drug in this study.
Hepatic impaired subjects:
- Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.
Sites / Locations
- The frist affiliated hospital of Fourth Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients with im paired hepatic function
Healthy Volunteers
Arm Description
One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection.
One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection.
Outcomes
Primary Outcome Measures
Area under the concentration time curve from 0 to infinity (AUC0-∞) after a single
Maximum observed plasma drug concentration (Cmax) after a single oral dose of
Time to maximum observed plasma drug concentration (Tmax) after a single oral dose of Imrecoxib.
Secondary Outcome Measures
Apparent terminal half-life (t½) after a single oral dose of Imrecoxib.
Apparent clearance (CL/F) after a single oral dose of Imrecoxib.
Full Information
NCT ID
NCT02456688
First Posted
April 21, 2015
Last Updated
May 26, 2015
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02456688
Brief Title
Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency
Official Title
An Open-label, Single-dose Study to Assess the Pharmacokinetics of Imrecoxib in Subjects With Impaired Hepatic Function
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in patients with impaired hepatic function as compared to healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with im paired hepatic function
Arm Type
Experimental
Arm Description
One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection.
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection.
Intervention Type
Drug
Intervention Name(s)
Imrecoxib
Primary Outcome Measure Information:
Title
Area under the concentration time curve from 0 to infinity (AUC0-∞) after a single
Time Frame
First 5 days
Title
Maximum observed plasma drug concentration (Cmax) after a single oral dose of
Time Frame
First 5 days
Title
Time to maximum observed plasma drug concentration (Tmax) after a single oral dose of Imrecoxib.
Time Frame
First 5 days
Secondary Outcome Measure Information:
Title
Apparent terminal half-life (t½) after a single oral dose of Imrecoxib.
Time Frame
First 5 days
Title
Apparent clearance (CL/F) after a single oral dose of Imrecoxib.
Time Frame
First 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All subjects:
Between the ages of 18 to 70 years, with BMI 18~ 29kg/m2.
In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory test values(except for values related to hepatic insufficiency).
Hepatic impaired subjects:
Hepatocirrhosis subjects verified by B-mode ultrasonography,CT ,MRI or Biopsy.
A Child-Pugh Classification score clinically determined as Class B.
Exclusion Criteria:
All subjects:
History of hypersensitivity to Imrecoxib or its components.
Subjects diagnosed with tumor.
History of or current clinically important systemic illnesses, including but not limited to cardiovascular, pulmonary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological, or psychiatric diseases.
Have used any drugs or substances (including herbal supplements) known to inhibit or induce cytochrome P450 enzymes including cytochrome P450 3A4, cytochrome P450 2C8 and cytochrome P450 2C9 within 28 days prior to the first dose and throughout the study.
Have taken other investigational drugs or participated in any clinical trial within 90 days prior to first dose of study drug in this study.
Hepatic impaired subjects:
Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.
Facility Information:
Facility Name
The frist affiliated hospital of Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
aidong Wen, Ph.D
Phone
029-84773636
Email
adwen@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
aidong Wen, Ph.D
First Name & Middle Initial & Last Name & Degree
xinmin Zhou, Ph.D
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency
We'll reach out to this number within 24 hrs