Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT00812305
Status:
COMPLETED
Last Update Posted:
2010-09-08
First Post:
2008-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hepatic Impairment Study: Pharmacokinetics in Healthy and Hepatically Impaired Subjects
Sponsor:
Pacira Pharmaceuticals, Inc
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Phase 1 Study to Assess the Pharmacokinetics and Safety of SKY0402 in Subjects With Impaired Hepatic Function
Status:
COMPLETED
Status Verified Date:
2010-09
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:
Review differences between how a healthy person and how a person with liver problems handles the study drug.
Detailed Description:
Evaluate the pharmacokinetic (PK) profile of SKY0402 in subjects with moderate hepatic impairment compared with age-, gender-, and weight-matched control subjects with normal hepatic function.
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?: