NCT01452828

A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	TR-701 FA single infusion	Single IV infusion, 200 mg daily for 7 days
DRUG	TR-701 FA	Two separate infusions of 200 mg
DRUG	TR-701 FA	Single IV infusion, 200 mg daily for 7 days

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-10-17
• Last updated: 2016-05-03

Locations

2 sites across 1 country: United States