NCT01461460|CompletedPhase 1
A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram
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A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram
Sponsor study identifier
Secondary identifiers
OTHER · TriusRX unique ID
interventional
48
1 country
1
Study Start
November 28, 2011
Actual (reported)Primary Completion
December 23, 2011
Actual (reported)Study Completion
December 23, 2011
Actual (reported)The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 23, 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 26, 2011
Actual (reported)October 28, 2011
Actual (reported)November 28, 2011
Actual (reported)December 23, 2011
Actual (reported)December 23, 2011
Actual (reported)QTcF Change from Baseline
Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).
24 Hours
6 tablet of T-701 FA
Trius Investigator
Dallas, Texas, 75247, United States
Flanagan S, Litwin J, Fang E, Prokocimer P. Effects of therapeutic and supratherapeutic doses of oral tedizolid phosphate on cardiac repolarisation in healthy volunteers: a randomised controlled study. Int J Antimicrob Agents. 2016 Jul;48(1):33-40. doi: 10.1016/j.ijantimicag.2015.12.015. Epub 2016 Jun 2.
Philippe G Prokocimer, MD
Trius Therapeutics
48 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2011
First Posted
October 28, 2011
Study Start
November 28, 2011
Actual (reported)A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects
1 tablet of TR-701 FA with 5 tablet placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 23, 2011
Actual (reported)Study Completion
December 23, 2011
Actual (reported)Last Updated
December 5, 2018
Record last verified: 2018-12
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Source: ClinicalTrials.gov.
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