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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal Hepatic Function

Intervention Drug: Hydrocodone bitartrate extended-release tablet

Group Type EXPERIMENTAL

Hydrocodone bitartrate extended-release tablet

Intervention Type DRUG

15 mg (single dose)

Moderate Hepatic Impairment

Intervention Drug: Hydrocodone bitartrate extended-release tablet

Group Type EXPERIMENTAL

Hydrocodone bitartrate extended-release tablet

Intervention Type DRUG

15 mg (single dose)

Interventions

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Hydrocodone bitartrate extended-release tablet

15 mg (single dose)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes