Back to resultsA Pharmacokinetics and Safety Study in Subjects With Renal Impairment
Primary Purpose
Renal Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TR-701 FA single infusion
TR-701 FA
TR-701 FA
Sponsored by
About this trial
This is an interventional treatment trial for Renal Impairment focused on measuring Renal Impairment
Eligibility 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
Sites / Locations
- Trius Investigator Site 001
- Trius Investigator Site 002
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Renal Impairment Nondialyzed
Renal Impairment Dialyzed
Matched Control
Arm Description
Outcomes
Primary Outcome Measures
Composite (or Profile) of Pharmacokinetics
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01452828
Brief Title
A Pharmacokinetics and Safety Study in Subjects With Renal Impairment
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trius Therapeutics LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
Renal Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renal Impairment Nondialyzed
Arm Type
Experimental
Arm Title
Renal Impairment Dialyzed
Arm Type
Experimental
Arm Title
Matched Control
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TR-701 FA single infusion
Other Intervention Name(s)
Tedizolid
Intervention Description
Single IV infusion, 200 mg daily for 7 days
Intervention Type
Drug
Intervention Name(s)
TR-701 FA
Other Intervention Name(s)
Tedizolid
Intervention Description
Two separate infusions of 200 mg
Intervention Type
Drug
Intervention Name(s)
TR-701 FA
Other Intervention Name(s)
Tedizolid
Intervention Description
Single IV infusion, 200 mg daily for 7 days
Primary Outcome Measure Information:
Title
Composite (or Profile) of Pharmacokinetics
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Prokocimer, MD
Organizational Affiliation
Trius Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Trius Investigator Site 001
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Trius Investigator Site 002
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25136024
Citation
Flanagan S, Minassian SL, Morris D, Ponnuraj R, Marbury TC, Alcorn HW, Fang E, Prokocimer P. Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment. Antimicrob Agents Chemother. 2014 Nov;58(11):6471-6. doi: 10.1128/AAC.03431-14. Epub 2014 Aug 18.
Results Reference
derived
Learn more about this trial
A Pharmacokinetics and Safety Study in Subjects With Renal Impairment
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