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A Pharmacokinetics and Safety Study in Subjects With Renal Impairment

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ClinicalTrials.gov Identifier: NCT01452828
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: TR-701 FA single infusion Drug: TR-701 FA Phase 1

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Renal Impairment Nondialyzed Drug: TR-701 FA single infusion
Single IV infusion, 200 mg daily for 7 days
Other Name: Tedizolid

Experimental: Renal Impairment Dialyzed Drug: TR-701 FA
Two separate infusions of 200 mg
Other Name: Tedizolid

Experimental: Matched Control Drug: TR-701 FA
Single IV infusion, 200 mg daily for 7 days
Other Name: Tedizolid




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452828


Locations
United States, Florida
Trius Investigator Site 001
Orlando, Florida, United States, 32809
United States, Minnesota
Trius Investigator Site 002
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Trius Therapeutics LLC
Investigators
Study Chair: Philippe Prokocimer, MD Trius Therapeutics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01452828     History of Changes
Other Study ID Numbers: 1986-031
TR701-123 ( Other Identifier: TriusRX Unique ID )
First Posted: October 17, 2011    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016

Keywords provided by Trius Therapeutics LLC:
Renal Impairment

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Torezolid phosphate
Torezolid
Anti-Bacterial Agents
Anti-Infective Agents