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

NCT01319279 | Completed Phase 1

• 1 other identifier: C33237/1089
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

1. 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. 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.

Conditions

Hepatic Impairment

Keywords

Pharmacokinetics; Hydrocodone; Extended Release; Hepatic impairment

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (AUC and Cmax) after a single dose

  7 days

Secondary Outcomes (1)

• 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)

Study Arms (2)

Normal Hepatic Function

EXPERIMENTAL

Intervention Drug: Hydrocodone bitartrate extended-release tablet

Drug: Hydrocodone bitartrate extended-release tablet

Moderate Hepatic Impairment

EXPERIMENTAL

Intervention Drug: Hydrocodone bitartrate extended-release tablet

Drug: Hydrocodone bitartrate extended-release tablet

Interventions

Hydrocodone bitartrate extended-release tablet DRUG

15 mg (single dose)

Moderate Hepatic Impairment; Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects:
• Written informed consent is obtained
• 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.
• 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).

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (1)

Orlando Clinical Research

Orlando, Florida, 32809, United States

Location

Study Officials

• Sponsor's Medical Expert

  Cephalon, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 21, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

US (1)