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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cephalon
• Treatments: Hydrocodone

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.