Knee OsteoarthritisPhase 1NCT02456688
Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency
A Phase 1 study testing Imrecoxib in people with Knee Osteoarthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Imrecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jul 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The frist affiliated hospital of Fourth Military Medical University
Xi’an, Shanxi, 710032
aidong Wen, Ph.D, 029-84773636, adwen@fmmu.edu.cn
aidong Wen, Ph.D
About this study
Official title: An Open-label, Single-dose Study to Assess the Pharmacokinetics of Imrecoxib in Subjects With Impaired Hepatic Function
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
- Being tested
- Imrecoxib
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImrecoxibDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients with im paired hepatic function | Experimental | One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection. Receives: Drug: Imrecoxib |
| Healthy Volunteers | Experimental | One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection. Receives: Drug: Imrecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve from 0 to infinity (AUC0-∞) after a single
Measured: First 5 days
Maximum observed plasma drug concentration (Cmax) after a single oral dose of
Measured: First 5 days
Time to maximum observed plasma drug concentration (Tmax) after a single oral dose of Imrecoxib.
Measured: First 5 days
Secondary outcomes (2)
Apparent terminal half-life (t½) after a single oral dose of Imrecoxib.
Measured: First 5 days
Apparent clearance (CL/F) after a single oral dose of Imrecoxib.
Measured: First 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456688
- Sponsor's protocol ID
- ARXB00434L
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose Study to Assess the Pharmacokinetics of Imrecoxib in Subjects With Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT02456688
- Acronym / sponsor ID
- ARXB00434L
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in patients with impaired hepatic function as compared to healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with im paired hepatic function | Experimental | Drug: ImrecoxibOne dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection. |
| Healthy Volunteers | Experimental | Drug: ImrecoxibOne dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
- Hepatocirrhosis subjects verified by B-mode ultrasonography,CT ,MRI or Biopsy.
- A Child-Pugh Classification score clinically determined as Class B.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imrecoxib | Drug | Healthy Volunteers, Patients with im paired hepatic function |
Primary outcome
Area under the concentration time curve from 0 to infinity (AUC0-∞) after a single
Time frame: First 5 days
Maximum observed plasma drug concentration (Cmax) after a single oral dose of
Time frame: First 5 days
Time to maximum observed plasma drug concentration (Tmax) after a single oral dose of Imrecoxib.
Time frame: First 5 days
2 secondary outcomes
Apparent terminal half-life (t½) after a single oral dose of Imrecoxib.
Time frame: First 5 days
Apparent clearance (CL/F) after a single oral dose of Imrecoxib.
Time frame: First 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The frist affiliated hospital of Fourth Military Medical University
Xi’an, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Imrecoxib in people with Knee Osteoarthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration time curve from 0 to infinity (AUC0-∞) after a single (time frame: First 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.