Pharmacokinetics and Metabolism of Hydrocodone Bitartrate Controlled-Release (HC-CR) in Subjects With Hepatic Impairment

November 8, 2022 updated by: Zogenix, Inc.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pharmacokinetics and relative bioavailability of hydrocodone and its metabolites under fasted conditions

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All hepatically-impaired subjects must have meet all of the following inclusion criteria to be enrolled into the study:
  2. Male or non-pregnant, non-lactating females. Subjects were aged 18-80 years, inclusive.
  3. 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.
  4. 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.
  5. 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).
  6. Subjects voluntarily provided written informed consent.

  7. 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.

Exclusion Criteria:

  1. Women who were pregnant or breastfeeding
  2. Any clinically significant condition that would, in the opinion of the Investigator, preclude study participation
  3. 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.
  4. Body Mass Index (BMI) >40 kg/m2.
  5. Known allergy or hypersensitivity to hydrocodone, or other opioids.
  6. Had taken any investigational drug within 30 days prior to the Day 1 Visit or currently enrolled in another investigational drug study.
  7. Had used a monoamine oxidase inhibitor within 14 days prior to Day 1.
  8. Been taking opioids during the 30 days prior to Day 1 or needing to take opioids during the study period
  9. 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.
  10. 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.
  11. Positive quantitative urine drug screen for illicit drugs, or non-prescribed controlled substances at Screening.
  12. Had made a plasma donation within 7 days prior to Day 1.
  13. Had made any significant donation or loss of blood within 56 days prior to Day 1.
  14. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mild Hepatic Impairment
20 mg HC-ER
Drug: 20 mg HC-ER
1-72 hours
Other Names:
  • Zohydro ER
Experimental: Moderate Hepatic Impairment
20 mg HC-ER
Drug: 20 mg HC-ER
1-72 hours
Other Names:
  • Zohydro ER
Experimental: No Hepatic Impairment
20 mg HC-ER
Drug: 20 mg HC-ER
1-72 hours
Other Names:
  • Zohydro ER

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 1-3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zogenix, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kenneth Lasseter, MD, Zogenix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZX002-1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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