Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency

NCT02456688 | Unknown Phase 1 DMC

• 1 other identifier: ARXB00434L
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (2)

Patients with im paired hepatic function

EXPERIMENTAL

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

Drug: Imrecoxib

Healthy Volunteers

EXPERIMENTAL

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

Drug: Imrecoxib

Interventions

Imrecoxib DRUG

Healthy Volunteers; Patients with im paired hepatic function

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The frist affiliated hospital of Fourth Military Medical University

Xi’an, Shanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Imrecoxib

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: May 28, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-04

Locations

CN (1)