Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Drug: Imrecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02456688

ARXB00434L

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Patients with im paired hepatic function

Experimental group

Description:

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

Treatment:

Drug: Imrecoxib

Healthy Volunteers

Experimental group

Description:

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

Treatment:

Drug: Imrecoxib