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

NCT02242734 | Completed Phase 1

• 1 other identifier: ZX002-1001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Determine the influence of hepatic impairment on the pharmacokinetics and metabolism of Hydrocodone Bitartrate Extended-Release (HC-ER) 20 mg capsules

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1-3

Study Arms (3)

Mild Hepatic Impairment

EXPERIMENTAL

20 mg HC-ER

Drug: 20 mg HC-ER

Moderate Hepatic Impairment

EXPERIMENTAL

20 mg HC-ER

Drug: 20 mg HC-ER

No Hepatic Impairment

EXPERIMENTAL

20 mg HC-ER

Drug: 20 mg HC-ER

Interventions

20 mg HC-ER DRUG

1-72 hours

Also known as: Zohydro ER

Mild Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects, in the Investigator's opinion, were able to complete study procedures
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zogenix, Inc.: lead

MeSH Terms

Interventions

Hydrocodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Kenneth Lasseter, MD

  Zogenix, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: September 17, 2014
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 10, 2022

Record last verified: 2014-09