PainPhase 1NCT00812305
Hepatic Impairment Study: Pharmacokinetics in Healthy and Hepatically Impaired Subjects
A Phase 1 study testing SKY0402 300mg in healthy patients and SKY0402 300mg in hepatically impaired patients in people with Pain and Hepatic Impairment, run by Pacira Pharmaceuticals, Inc at 1 site in Poland.
Trial summary
Review differences between how a healthy person and how a person with liver problems handles the study drug. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Hepatic Impairment
- What is being tested?
- SKY0402 300mg in healthy patients and SKY0402 300mg in hepatically impaired patients
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2009to Aug 2009
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Subjects:
- Male or female, ages 18-65 years, inclusive, at Screening. Eligible female subjects of childbearing potential with a nonsterilized male sexual partner must agree to use a hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device beginning >30 days prior to study drug administration and continuing until >7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for >1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the subject's follicle stimulating hormone (FSH) level must be checked and must be elevated and consistent with postmenopausal levels (i.e., >40 IU/L); otherwise these subjects must agree to use contraceptives listed above.
- Able and willing to comply with all study visits and procedures, including returning as scheduled for post-treatment visits.
- Able to speak, read, and understand the language of the informed consent, and any other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to study assessments.
- Willing and capable of providing written informed consent.
- Subjects with Hepatic Impairment:
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- Subjects must have a positive diagnosis of liver cirrhosis (hepatic fibrosis with evidence of either micro- or macro-nodular regeneration) that has been stable for two months and is confirmed by imaging techniques, biopsy, or physical signs consistent with a clinical diagnosis of liver cirrhosis (e.g., liver firmness to palpation, splenic enlargement, spider angiomata, palmar erythema, parotid hypertrophy, testicular atrophy, gynecomastia).
- Subjects must have an impaired but stable hepatic function evidenced by Child-Pugh Clinical Assessment Score between 7 and 9 at both screening and baseline.
- Control Subjects with Normal Hepatic Function:
- Subjects must be in general good health as determined by past medical history, physical examination, vital signs, electrocardiogram, Chest X-Ray (CXR), and laboratory tests at screening.
- Subjects should be matched to a hepatically impaired subject in gender, age (±15%) and weight (±20%).
Who cannot join
- All Subjects
- A history of hypersensitivity to amide type local anesthetics.
- Pregnancy, nursing, or planning to become pregnant during the course of the study.
- Body weight less than 60 kg (~132 lbs) or more than 120 kg (~264 lbs).
- BMI of less than 18 or more than 35 kg/m2
- Significant acute, new onset illness (e.g., flu, gastroenteritis) within two weeks prior to study treatment administration.
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- Clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, neurological, or psychiatric disease that may pose a significant safety risk or diminish subject's ability to undergo all study procedures and assessments
- History of immunocompromised status, including a positive HIV (ELISA and Western blot) test result.
- Evidence of active alcohol or drug abuse as indicated by the tests conducted during the screening or baseline evaluations; subject must state they are willing to remain alcohol and drug free for three weeks after study drug administration.
- Use of ASA within 10 days prior to study drug administration.
- Use of Lidocaine, mepivacaine, etidocaine, ropivacaine, and any amide-type anesthetics in any form within 5 elimination half-lives.
- Use of any local anesthetic within 3 days prior to study drug administration.
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
- Any condition that, in the opinion of the Investigator, renders a subject unsuitable for participation in the study. NOTE: A specific rationale must be provided and documented for excluding all prospective subjects deemed unsuitable for the study.
- Subjects with Hepatic Impairment:
- Clinically significant abnormal findings other than hepatic impairment.
- Clinical evidence of severe ascites, as judged by the investigator.
- History of surgical portosystemic shunt.
- Fluctuating or rapidly deteriorating hepatic function as indicated by recent history or by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period.
- On active Hepatitis treatment with Interferon or other excluded medications (see Appendix 4)
- Control Subjects with Normal Hepatic Function:
- Prohibited prescription medications within 14 days prior to dosing; see Appendix 4 for specific medications.
- History or presence of liver disease or liver injury as indicated by an abnormal liver function profile such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin.
- Hepatitis B as indicated by positive HBs Ag, or Hepatitis C as indicated by positive anti-HCV result.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Phase 1 Study to Assess the Pharmacokinetics and Safety of SKY0402 in Subjects With Impaired Hepatic Function
Review differences between how a healthy person and how a person with liver problems handles the study drug.
Read the detailed description
Evaluate the pharmacokinetic (PK) profile of SKY0402 in subjects with moderate hepatic impairment compared with age-, gender-, and weight-matched control subjects with normal hepatic function.
- Conditions
- Pain, Hepatic Impairment
- Being tested
- SKY0402 300mg in healthy patients, SKY0402 300mg in hepatically impaired patients
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKY0402 300mg in healthy patientsDrug
Also called Healthy and Hepatic Impaired subjects will receive SKY0402.
SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in healthy patients
SKY0402 300mg in hepatically impaired patientsDrug
Also called Healthy and Hepatic Impaired subjects will receive SKY0402.
SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in hepatically impaired patients
| Study group | Role | What they receive |
|---|---|---|
| Low dose in healthy patients | Experimental | Not described Receives: Drug: SKY0402 300mg in healthy patients |
| Low dose in hepatically impaired patients | Experimental | Not described Receives: Drug: SKY0402 300mg in hepatically impaired patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum plasma concentration of SKY0402
Measured: Multiple through 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janusz Rupinski, Study director, Pharm-Olam International Polska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812305
- Sponsor's protocol ID
- SKY0402C110
- Status last verified
- Sep 2010
- First submitted
- 9 Dec 2008
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase 1 Study to Assess the Pharmacokinetics and Safety of SKY0402 in Subjects With Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT00812305
- Acronym / sponsor ID
- SKY0402C110
- Conditions
- Pain, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Dec 2008 (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.
Review differences between how a healthy person and how a person with liver problems handles the study drug.
Detailed description
Evaluate the pharmacokinetic (PK) profile of SKY0402 in subjects with moderate hepatic impairment compared with age-, gender-, and weight-matched control subjects with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose in healthy patients | Experimental | Drug: SKY0402 300mg in healthy patients |
| Low dose in hepatically impaired patients | Experimental | Drug: SKY0402 300mg in hepatically impaired patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, ages 18-65 years, inclusive, at Screening. Eligible female subjects of childbearing potential with a nonsterilized male sexual partner must agree to use a hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device beginning >30 days prior to study drug administration and continuing until >7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for >1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the subject's follicle stimulating hormone (FSH) level must be checked and must be elevated and consistent with postmenopausal levels (i.e., >40 IU/L); otherwise these subjects must agree to use contraceptives listed above.
- Able and willing to comply with all study visits and procedures, including returning as scheduled for post-treatment visits.
- Able to speak, read, and understand the language of the informed consent, and any other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to study assessments.
- Willing and capable of providing written informed consent.
- Subjects must have a positive diagnosis of liver cirrhosis (hepatic fibrosis with evidence of either micro- or macro-nodular regeneration) that has been stable for two months and is confirmed by imaging techniques, biopsy, or physical signs consistent with a clinical diagnosis of liver cirrhosis (e.g., liver firmness to palpation, splenic enlargement, spider angiomata, palmar erythema, parotid hypertrophy, testicular atrophy, gynecomastia).
Key exclusion criteria (24 listed)
- All Subjects
- A history of hypersensitivity to amide type local anesthetics.
- Pregnancy, nursing, or planning to become pregnant during the course of the study.
- Body weight less than 60 kg (~132 lbs) or more than 120 kg (~264 lbs).
- BMI of less than 18 or more than 35 kg/m2
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 |
|---|---|---|
| SKY0402 300mg in healthy patientsAlso: Healthy and Hepatic Impaired subjects will receive SKY0402.SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in healthy patients | Drug | Low dose in healthy patients |
| SKY0402 300mg in hepatically impaired patientsAlso: Healthy and Hepatic Impaired subjects will receive SKY0402.SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in hepatically impaired patients | Drug | Low dose in hepatically impaired patients |
Primary outcome
Serum plasma concentration of SKY0402
Time frame: Multiple through 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
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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.
Janusz Rupinski study director
Pharm-Olam International Polska
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 SKY0402 300mg in healthy patients and SKY0402 300mg in hepatically impaired patients in people with Pain and Hepatic Impairment, run by Pacira Pharmaceuticals, Inc at 1 site in Poland.
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 11 inclusion and 24 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: finished, as of the sponsor's last update on 8 Sep 2010. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum plasma concentration of SKY0402 (time frame: Multiple through 96 hours). 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 8 Sep 2010.