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A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

Renal Impairment Clinical Trial

Official title:
A Phase I Open-Label Study With 200 mg Intravenous TR-701 Free Acid to Assess Safety and Pharmacokinetics in Advanced Renal Impairment Subjects

Clinical Trial Summary

The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.

Clinical Trial Description

To assess the pharmacokinetics (PK) and evaluate the safety of intravenous (IV) infusion of TR-701 free acid (FA) in subjects with advanced renal impairment compared with matched control subjects with normal renal function ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01452828
Study type Interventional
Source Trius Therapeutics LLC
Contact
Status Completed
Phase Phase 1
Start date October 2011
Completion date March 2012
View Details
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