A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

May 2, 2016 updated by: Trius Therapeutics LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32809
        • Trius Investigator Site 001
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Trius Investigator Site 002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal Impairment Nondialyzed
Drug: TR-701 FA single infusion
Single IV infusion, 200 mg daily for 7 days
Other Names:
  • Tedizolid
Experimental: Renal Impairment Dialyzed
Drug: TR-701 FA
Two separate infusions of 200 mg
Other Names:
  • Tedizolid
Drug: TR-701 FA
Single IV infusion, 200 mg daily for 7 days
Other Names:
  • Tedizolid
Experimental: Matched Control
Drug: TR-701 FA
Two separate infusions of 200 mg
Other Names:
  • Tedizolid
Drug: TR-701 FA
Single IV infusion, 200 mg daily for 7 days
Other Names:
  • Tedizolid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trius Therapeutics LLC

Investigators

  • Study Chair: Philippe Prokocimer, MD, Trius Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 21, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (Estimate)

October 17, 2011

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1986-031
  • TR701-123 (Other Identifier: TriusRX Unique ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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