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
Information source: Cephalon
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatic Impairment
Intervention: Hydrocodone bitartrate extended-release tablet (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Cephalon Official(s) and/or principal investigator(s):
Sponsor's Medical Expert, Study Director, Affiliation: Cephalon
Overall contact:
Cephalon Contact, Phone: 1-877-237-4879
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pharmacokinetics (AUC and Cmax) after a single dose
Secondary outcome: Safety (occurrence of adverse events, labs, ECG, physical exam, vital signs, oxygen saturation)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Cephalon Contact, Phone: 1-877-237-4879
Orlando Clinical Research, Orlando, Florida 32809, United States; Recruiting
Central Contact
Additional Information
Starting date: April 2011
Last updated: May 4, 2011
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