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

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT01319279

Run by

Cephalon

People needed

16

Starts

2011-04-01

Expected to finish

2011-08-01

Last updated by the study team

2012-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All subjects:
• Written informed consent is obtained
• 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.
• 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).

You may not qualify if…

• 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.
• 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.
• 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.

Where it is running

• Orlando Clinical Research — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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