Hepatic Impairment
Conditions
Keywords
Pharmacokinetics, Hydrocodone, Extended Release, Hepatic impairment
Brief 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.
Interventions
15 mg (single dose)
Sponsors
Cephalon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (AUC and Cmax) after a single dose | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety (occurrence of adverse events, labs, ECG, physical exam, vital signs, oxygen saturation) | throughout the 37 day study period (includes screening, drug administration and pharmacokinetics sampling period, and follow-up) |
Countries
United States
Outcome results
None listed