Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-27 @ 7:33 AM
Study NCT ID:
NCT01319266
Status:
COMPLETED
Last Update Posted:
2012-04-24
First Post:
2011-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Renal Function and Subjects With Varying Degrees of Renal Impairment
Sponsor:
Cephalon
Organization:
Study Overview
Official Title:
An Open-Label, Single-Dose Study to Assess the Pharmacokinetics of the Hydrocodone Bitartrate Extended-Release Tablet (45 mg) in Subjects With Normal Renal Function and Subjects With Varying Degrees of Renal Impairment
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the effect of varying degrees of renal impairment (mild, moderate, severe and end stage renal disease) compared with subjects with normal renal function on the pharmacokinetics of the hydrocodone bitartrate extended-release tablet.
Detailed Description:
This is a multicenter, open-label, parallel-group pharmacokinetic and safety study to assess the effect of varying degrees of renal impairment (mild, moderate, severe and end stage renal disease \[ESRD\])on the pharmacokinetics of the hydrocodone bitartrate extended-release tablet at a single dose of 45 mg as compared with subjects with normal renal function. The study consists of a screening visit within 28 days before study drug administration (visit 1), followed by a single-dose administration period including a 144-hour pharmacokinetic sampling period (visit 2) with a final assessment after the final pharmacokinetic sample is collected or upon early withdrawal, and a follow-up visit 48 to 72 hours after the last discharge from the study center (visit 3). Subjects will be categorized into either the control group with normal renal function or one of the four groups of subjects with varying degrees of renal impairment. Up to 12 subjects in each of the 4 renal impairment groups and up to 16 subjects with normal renal function will be enrolled to achieve the targeted minimum of 8 subjects in each renal impairment group and 10 subjects with normal renal function completing the study. Eligible subjects will check in to the study center on day -1. Subjects who continue to meet the criteria for enrollment will receive a single dose of the hydrocodone bitartrate extended-release tablet on day 1. Subjects will receive one 50-mg tablet of naltrexone hydrochloride to block opioid receptors and minimize opioid related adverse events approximately 15 and 3 hours before and approximately 9 and 21 hours after study drug administration. Blood and urine samples will be collected just before study drug administration and over a 144-hour period after study drug administration. Safety will be assessed throughout the study by monitoring the occurrence of adverse events, clinical laboratory test results, vital signs measurements,12-lead ECG findings, physical examination findings, SpO2 findings, and use of concomitant medications. Subjects who complete all scheduled visits will have final procedures and assessments performed prior to discharge from the study center after pharmacokinetic sampling is complete. All subjects will be asked to return for a follow-up visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: