Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02456688
• Other study ID #: ARXB00434L
• Status: Recruiting
• Phase: Phase 1
• First received: April 21, 2015
• Last updated: May 26, 2015
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: April 2015
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Imrecoxib

Locations

Country	Name	City	State
China	The frist affiliated hospital of Fourth Military Medical University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration time curve from 0 to infinity (AUC0-8) after a single		First 5 days	No
Primary	Maximum observed plasma drug concentration (Cmax) after a single oral dose of		First 5 days	No
Primary	Time to maximum observed plasma drug concentration (Tmax) after a single oral dose of Imrecoxib.		First 5 days	No
Secondary	Apparent terminal half-life (t½) after a single oral dose of Imrecoxib.		First 5 days	No
Secondary	Apparent clearance (CL/F) after a single oral dose of Imrecoxib.		First 5 days	No