Expired Study
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Orlando, Florida 32809


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.


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.


NCT ID:

NCT01319279


Primary Contact:

Study Director
Sponsor's Medical Expert
Cephalon


Backup Contact:

N/A


Location Contact:

Orlando, Florida 32809
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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