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

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: Hydrocodone bitartrate extended-release tablet

• Registration Number: NCT01319279
• Lead Sponsor: Cephalon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Study Start: 2011-04
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-20
• Last Update Posted: 2012-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate Hepatic Impairment	Hydrocodone bitartrate extended-release tablet	Intervention Drug: Hydrocodone bitartrate extended-release tablet
Normal Hepatic Function	Hydrocodone bitartrate extended-release tablet	Intervention Drug: Hydrocodone bitartrate extended-release tablet

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (AUC and Cmax) after a single dose	7 days

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Orlando Clinical Research; 🇺🇸 Orlando, Florida, United States