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

Hepatic Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319279
• Other study ID #: C33237/1089
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2011
• Last updated: April 20, 2012
• Start date: April 2011
• Est. completion date: August 2011

Study information

• Verified date: April 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Hydrocodone bitartrate extended-release tablet
15 mg (single dose)

Locations

Country	Name	City	State
United States	Orlando Clinical Research	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (AUC and Cmax) after a single dose		7 days	No
Secondary	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)	Yes