Hepatic ImpairmentPhase 1NCT02242734
Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment
A Phase 1 study testing 20 mg HC-ER in people with Hepatic Impairment, run by Zogenix, Inc..
Trial summary
Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- 20 mg HC-ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to May 2011
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All hepatically-impaired subjects must have meet all of the following inclusion criteria to be enrolled into the study:
- Male or non-pregnant, non-lactating females. Subjects were aged 18-80 years, inclusive.
- Subjects must have been a clinical diagnosis of chronic hepatic impairment for duration of at least 6 months classified as mild or moderate as per Child-Pugh classification.
- Hepatic insufficiency was stable with no acute episodes of illness within the previous 2 months due to deterioration of hepatic function due to any etiology.
- Female subjects of childbearing potential including those who had a tubal ligation surgery but excluded those who did not have a menstrual period for a minimum of 2 years, had a negative pregnancy test at the Screening and Day -1 visits, and consented to use a medically-acceptable method of contraception throughout the entire study period and for 1 week after the study completed. Medically acceptable methods of contraception included were not limited to abstinence, birth control pills or patches, vaginal rings, diaphragm with vaginal spermicide, Intrauterine Device, and progestin implant or injection (used consistently for 3 months prior to study dosing).
- Subjects voluntarily provided written informed consent.
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- Subjects, in the Investigator's opinion, were able to complete study procedures
- All healthy control subjects must have met all hepatic subject inclusion criteria as outlined above with the exception of Inclusion Criteria 3 \& 4 above which should be substituted with the following to be enrolled into the study:
- Must have been matched by age (±10 years) and Body Mass Index (BMI) (± 10% of BMI) with some consideration for race and gender to subjects with hepatic impairment.
- Were medically healthy with no clinically significant abnormalities in their laboratory profile as deemed by the Investigator.
Who cannot join
- Women who were pregnant or breastfeeding
- Any clinically significant condition that would, in the opinion of the Investigator, preclude study participation
- Uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure 180 mmHg or 90 mmHg, and/or a sitting diastolic blood pressure 120 mmHg or 50 mmHg at Screening.
- Body Mass Index (BMI) >40 kg/m2.
- Known allergy or hypersensitivity to hydrocodone, or other opioids.
- Had taken any investigational drug within 30 days prior to the Day 1 Visit or currently enrolled in another investigational drug study.
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- Had used a monoamine oxidase inhibitor within 14 days prior to Day 1.
- Been taking opioids during the 30 days prior to Day 1 or needing to take opioids during the study period
- Positive for human immunodeficiency virus (HIV). Healthy control subjects must not have been hepatitis C virus (HCV) positive, hepatically-impaired subjects could be HCV positive but should not have been receiving treatment.
- History of any illicit substance abuse in the past 2 years or any history of opioid abuse. Subjects should not have been current abusers of alcohol and must have had a negative serum alcohol level at Screening and Day -1.
- Positive quantitative urine drug screen for illicit drugs, or non-prescribed controlled substances at Screening.
- Had made a plasma donation within 7 days prior to Day 1.
- Had made any significant donation or loss of blood within 56 days prior to Day 1.
- Had taken CYP2D6 and/or CYP3A4 inhibitors within 7 days prior to Day 1 and/or CYP2D6 and/or CYP3A4 inducers within 21 days prior to Day 1.
About this study
Official title: Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate Extended-Release (HC-ER) 20mg Capsules
Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules
Read the detailed description
Pharmacokinetics and relative bioavailability of hydrocodone and its metabolites under fasted conditions
- Conditions
- Hepatic Impairment
- Being tested
- 20 mg HC-ER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mg HC-ERDrug
Also called Zohydro ER
1-72 hours
20 mg HC-ERDrug
Also called Zohydro ER
1-72 hours
20 mg HC-ERDrug
Also called Zohydro ER
1-72 hours
| Study group | Role | What they receive |
|---|---|---|
| Mild Hepatic Impairment | Experimental | 20 mg HC-ER Receives: Drug: 20 mg HC-ER |
| Moderate Hepatic Impairment | Experimental | 20 mg HC-ER Receives: Drug: 20 mg HC-ER |
| No Hepatic Impairment | Experimental | 20 mg HC-ER Receives: Drug: 20 mg HC-ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of hydrocodone and its metabolites of 20 mg HC-ER
PK parameters including Cmax, Tmax, , AUC 0-t, AUC 0-inf, T1/2 and Kel
Measured: Day 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zogenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Lasseter, MD, Study director, Zogenix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242734
- Sponsor's protocol ID
- ZX002-1001
- Status last verified
- Sep 2014
- First submitted
- 19 Aug 2014
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Hepatic Impairment on the Pharmacokinetics and Metabolism of Hydrocodone and Its Metabolites Following Administration of Hydrocodone Bitartrate Extended-Release (HC-ER) 20mg Capsules
- ClinicalTrials.gov ID
- NCT02242734
- Acronym / sponsor ID
- ZX002-1001
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zogenix, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Sep 2014 (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.
Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules
Detailed description
Pharmacokinetics and relative bioavailability of hydrocodone and its metabolites under fasted conditions
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Hepatic Impairment | Experimental | Drug: 20 mg HC-ER20 mg HC-ER |
| Moderate Hepatic Impairment | Experimental | Drug: 20 mg HC-ER20 mg HC-ER |
| No Hepatic Impairment | Experimental | Drug: 20 mg HC-ER20 mg HC-ER |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All hepatically-impaired subjects must have meet all of the following inclusion criteria to be enrolled into the study:
- Male or non-pregnant, non-lactating females. Subjects were aged 18-80 years, inclusive.
- Subjects must have been a clinical diagnosis of chronic hepatic impairment for duration of at least 6 months classified as mild or moderate as per Child-Pugh classification.
- Hepatic insufficiency was stable with no acute episodes of illness within the previous 2 months due to deterioration of hepatic function due to any etiology.
- Female subjects of childbearing potential including those who had a tubal ligation surgery but excluded those who did not have a menstrual period for a minimum of 2 years, had a negative pregnancy test at the Screening and Day -1 visits, and consented to use a medically-acceptable method of contraception throughout the entire study period and for 1 week after the study completed. Medically acceptable methods of contraception included were not limited to abstinence, birth control pills or patches, vaginal rings, diaphragm with vaginal spermicide, Intrauterine Device, and progestin implant or injection (used consistently for 3 months prior to study dosing).
Key exclusion criteria (14 listed)
- Women who were pregnant or breastfeeding
- Any clinically significant condition that would, in the opinion of the Investigator, preclude study participation
- Uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure 180 mmHg or 90 mmHg, and/or a sitting diastolic blood pressure 120 mmHg or 50 mmHg at Screening.
- Body Mass Index (BMI) >40 kg/m2.
- Known allergy or hypersensitivity to hydrocodone, or other opioids.
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 |
|---|---|---|
| 20 mg HC-ERAlso: Zohydro ER1-72 hours | Drug | Mild Hepatic Impairment |
| 20 mg HC-ERAlso: Zohydro ER1-72 hours | Drug | Moderate Hepatic Impairment |
| 20 mg HC-ERAlso: Zohydro ER1-72 hours | Drug | No Hepatic Impairment |
Primary outcome
Pharmacokinetic profile of hydrocodone and its metabolites of 20 mg HC-ER
Time frame: Day 1-3
PK parameters including Cmax, Tmax, , AUC 0-t, AUC 0-inf, T1/2 and Kel
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 10 Nov 2022.
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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.
Kenneth Lasseter, MD study director
Zogenix, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 20 mg HC-ER in people with Hepatic Impairment, run by Zogenix, Inc..
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 10 inclusion and 14 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 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Pharmacokinetic profile of hydrocodone and its metabolites of 20 mg HC-ER (time frame: Day 1-3). 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 10 Nov 2022.