Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02456688

Collaborator

(none)

Enrollment

Location

Arms

5.9

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Imrecoxib	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2015

Anticipated Study Completion Date :

Jul 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Patients with im paired hepatic function

One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection.

Drug: Imrecoxib

Experimental: Healthy Volunteers

One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection.

Drug: Imrecoxib

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The frist affiliated hospital of Fourth Military Medical University	Xi'an	Shanxi	China	710032

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu HengRui Medicine Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02456688

Other Study ID Numbers:

ARXB00434L

First Posted:

May 28, 2015

Last Update Posted:

May 28, 2015

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of May 28, 2015