Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02456688

Enrollment

Registered

2015-05-28

Start date

2015-01-31

Completion date

2015-07-31

Last updated

2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

DRUGImrecoxib

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026