Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency

Study Overview
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Brief Summary
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This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in patients with impaired hepatic function as compared to healthy volunteers.

Official Title
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An Open-label, Single-dose Study to Assess the Pharmacokinetics of Imrecoxib in Subjects With Impaired Hepatic Function

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Imrecoxib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with im paired hepatic function<br>One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection. | Drug: Imrecoxib<br> <br> |
| Experimental: Healthy Volunteers<br>One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection. | Drug: Imrecoxib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration time curve from 0 to infinity (AUC0-∞) after a single |  | First 5 days | 
| Maximum observed plasma drug concentration (Cmax) after a single oral dose of |  | First 5 days | 
| Time to maximum observed plasma drug concentration (Tmax) after a single oral dose of Imrecoxib. |  | First 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apparent terminal half-life (t½) after a single oral dose of Imrecoxib. |  | First 5 days | 
| Apparent clearance (CL/F) after a single oral dose of Imrecoxib. |  | First 5 days |