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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:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT01319279
First received: March 17, 2011
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Pharmacokinetics (AUC and Cmax) after a single dose [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT01319279     History of Changes
Other Study ID Numbers: C33237/1089
Study First Received: March 17, 2011
Last Updated: April 20, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 17, 2013