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
2 other identifiers
interventional
24
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2011
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMay 3, 2016
May 1, 2016
5 months
September 21, 2011
May 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
Study Arms (3)
Renal Impairment Nondialyzed
EXPERIMENTALRenal Impairment Dialyzed
EXPERIMENTALMatched Control
EXPERIMENTALInterventions
Single IV infusion, 200 mg daily for 7 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Trius Investigator Site 001
Orlando, Florida, 32809, United States
Trius Investigator Site 002
Minneapolis, Minnesota, 55404, United States
Related Publications (1)
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.
PMID: 25136024DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Philippe Prokocimer, MD
Trius Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2011
First Posted
October 17, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
May 3, 2016
Record last verified: 2016-05