A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

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

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Trius Investigator Site 001, Orlando, Florida, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

BMI between 18.0 and 40.0 kg/m2 inclusive
Male or female subjects between 18 and 75 years of age
Stable dosage of medication for 30 days
for dialysis patients, receiving chronic and stable maintenance hemodialysis for at least 3 months

Exclusion criteria

Functioning transplanted solid organ
High tyramine diet
Significant, unstable, or life-threatening condition or organ or system condition or disease, other than kidney disease in renal subjects

Treatment and study plan

TR-701 FA single infusion

Drug

Single IV infusion, 200 mg daily for 7 days

Other names: Tedizolid

TR-701 FA

Drug

Two separate infusions of 200 mg

Other names: Tedizolid

Primary outcomes

Composite (or Profile) of Pharmacokinetics

Time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 hours post-dose

Cmax, Area Under Curve, Tmax t1/2 will be compared between each renal group and the control group, including calculation of geometric mean ratio and corresponding 90% confidence intervals.

Sponsors and collaborators

Lead sponsor

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Oct 17, 2011
Registry last updated: May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed