Hepatic ImpairmentPhase 1NCT01319279
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
A Phase 1 study testing Hydrocodone bitartrate extended-release tablet in people with Hepatic Impairment, run by Cephalon at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Hydrocodone bitartrate extended-release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Aug 2011
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is:
- To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function.
- 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
- Being tested
- Hydrocodone bitartrate extended-release tablet
- Keywords
- Pharmacokinetics, Hydrocodone, Extended Release, Hepatic impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocodone bitartrate extended-release tabletDrug
15 mg (single dose)
| Study group | Role | What they receive |
|---|---|---|
| Normal Hepatic Function | Experimental | Intervention Drug: Hydrocodone bitartrate extended-release tablet Receives: Drug: Hydrocodone bitartrate extended-release tablet |
| Moderate Hepatic Impairment | Experimental | Intervention Drug: Hydrocodone bitartrate extended-release tablet Receives: Drug: Hydrocodone bitartrate extended-release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (AUC and Cmax) after a single dose
Measured: 7 days
Secondary outcomes (1)
Safety (occurrence of adverse events, labs, ECG, physical exam, vital signs, oxygen saturation)
Measured: throughout the 37 day study period (includes screening, drug administration and pharmacokinetics sampling period, and follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor's Medical Expert, Study director, Cephalon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319279
- Sponsor's protocol ID
- C33237/1089
- Status last verified
- Apr 2012
- First submitted
- 17 Mar 2011
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No