NCT00812305

Hepatic Impairment Study: Pharmacokinetics in Healthy and Hepatically Impaired Subjects

A Randomized, Double-Blind, Phase 1 Study to Assess the Pharmacokinetics and Safety of SKY0402 in Subjects With Impaired Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	SKY0402 300mg in healthy patients	SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in healthy patients
DRUG	SKY0402 300mg in hepatically impaired patients	SKY0402, single administration of 300 mg via local infiltrations (subcutaneous) in hepatically impaired patients

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-12-22
• Last updated: 2010-09-08

Locations

1 site across 1 country: Poland