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

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • 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

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
Intervention / Treatment
Experimental: Mild Hepatic Impairment
20 mg HC-ER
1-72 hours
Other Names:
  • Zohydro ER
Experimental: Moderate Hepatic Impairment
20 mg HC-ER
1-72 hours
Other Names:
  • Zohydro ER
Experimental: No Hepatic Impairment
20 mg HC-ER
1-72 hours
Other Names:
  • Zohydro ER

What is the study measuring?

Primary Outcome Measures

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

Investigators

  • 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

February 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

September 1, 2014

More Information

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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