We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01319279
First Posted: March 21, 2011
Last Update Posted: April 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
  Purpose

The purpose of this study is:

  1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.
  2. To assess the safety and tolerability of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.

Condition Intervention Phase
Hepatic Impairment Drug: Hydrocodone bitartrate extended-release tablet Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose, Parallel-Group Study to Assess the Pharmacokinetics of the Hydrocodone Bitartrate Extended-Release Tablet (15 mg) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Cephalon ):

Primary Outcome Measures:
  • Pharmacokinetics (AUC and Cmax) after a single dose [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Safety (occurrence of adverse events, labs, ECG, physical exam, vital signs, oxygen saturation) [ Time Frame: throughout the 37 day study period (includes screening, drug administration and pharmacokinetics sampling period, and follow-up) ]

Enrollment: 16
Study Start Date: April 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal Hepatic Function
Intervention Drug: Hydrocodone bitartrate extended-release tablet
Drug: Hydrocodone bitartrate extended-release tablet
15 mg (single dose)
Experimental: Moderate Hepatic Impairment
Intervention Drug: Hydrocodone bitartrate extended-release tablet
Drug: Hydrocodone bitartrate extended-release tablet
15 mg (single dose)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All subjects:

    • Written informed consent is obtained
  2. Subjects with normal hepatic function:

    • The subject is in generally good health (age-appropriate) as determined by medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, coagulation, urinalysis, and serology.
  3. Subjects with hepatic impairment:

    • The subject's health is otherwise clinically stable as determined by medical history, physical examination, ECG, serum chemistry, hematology, coagulation parameters (PT, activated partial thromboplastin time [aPTT], and international normalized ratio [INR]), urinalysis, and serology except for those signs and symptoms attributable to liver disease.
    • The subject has case record notes demonstrating physical signs consistent with 1 or more of the following characteristic clinical manifestations of liver cirrhosis: liver firmness to palpation, splenic enlargement, spider angiomas, palmar erythema, parotid hypertrophy, testicular atrophy, ascites (accumulation of fluid in the abdominal cavity), or gynecomastia.
    • The subject has a Child-Pugh Classification score of 7-9 points (moderate).

Exclusion Criteria:

  1. All subjects:

    • The subject has any clinically significant, uncontrolled medical condition.
    • The subject is a poor metabolizer of CYP2D6 substrates based on genotyping performed at screening.
    • The subject has previously participated in a study with CEP-33237.
    • The subject has a known sensitivity or idiosyncratic reaction to hydrocodone or hydromorphone, related compounds, or to any metabolites, or any compound listed as being present in a study formulation.
  2. Subjects with normal hepatic function:

    • The subject has a positive test result for HBsAg or antibodies to hepatitis C.
    • The subject has a history of alcohol, narcotic, or any other substance abuse.
  3. Subjects with hepatic impairment:

    • The subject has severe ascites.
    • The subject has an acute exacerbation of liver disease as indicated by worsening clinical signs of hepatic impairment.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319279


Locations
United States, Florida
Orlando Clinical Research
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Cephalon
Investigators
Study Director: Sponsor's Medical Expert Cephalon
  More Information

Responsible Party: Cephalon
ClinicalTrials.gov Identifier: NCT01319279     History of Changes
Other Study ID Numbers: C33237/1089
First Submitted: March 17, 2011
First Posted: March 21, 2011
Last Update Posted: April 24, 2012
Last Verified: April 2012

Keywords provided by Teva Pharmaceutical Industries ( Cephalon ):
Pharmacokinetics
Hydrocodone
Extended Release
Hepatic impairment

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Hydrocodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents