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A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01461460
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : May 3, 2016
Information provided by (Responsible Party):

October 26, 2011
October 28, 2011
May 3, 2016
November 2011
December 2011   (Final data collection date for primary outcome measure)
QTcF Change from Baseline [ Time Frame: 24 Hours ]
Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).
Same as current
Complete list of historical versions of study NCT01461460 on ClinicalTrials.gov Archive Site
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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
The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.
To assess the effects of a single therapeutic (200 mg) and supratherapeutic of oral TR-701 free acid (FA) versus placebo on QT interval corrected for heart rate using Fridericia's formula (QTcF) in healthy subjects.
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Healthy Volunteer
  • Drug: TR-701 FA 1200 mg
    6 tablet of T-701 FA
    Other Name: Tedizolid
  • Drug: Moxifloxacin 400 mg
    1 tablet 400 mg Moxifloxacin
  • Drug: TR-701 FA 200 mg plus Placebo
    1 tablet of TR-701 FA with 5 tablet placebo
    Other Name: Tedizolid
  • Drug: Placebo
    6 placebo tablets
  • Active Comparator: Moxifloxacin 400 mg
    Intervention: Drug: Moxifloxacin 400 mg
  • Experimental: TR-701 FA 1200 mg
    Intervention: Drug: TR-701 FA 1200 mg
  • Experimental: TR-701 FA 200 mg plus Placebo
    Intervention: Drug: TR-701 FA 200 mg plus Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects between 18 and 45 years of age, inclusive.
  • Healthy males and females with no clinically significant abnormalities.
  • Body mass index ≥18.0 kg/m2 and ≤30.0 kg/m2

Exclusion Criteria:

  • Sustained supine systolic blood pressure >140 or <100 mmHg or a diastolic blood pressure >90 or <60 mmHg at the Screening and Day 1 Visit.
  • Abnormal ECG at Screening or Day -1 Visits indicating a second or third-degree atrioventricular block, or QRS >110 msec, QTcF >450 msec for males and >470 msec for females, PR interval >200 msec, or any rhythm other than sinus rhythm which is interpreted by the Investigator as clinically significant - History of unexplained infections or current signs of infection
  • History of risk factors for Torsades de Pointes, including unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, hypomagnesemia, or family history of Long QT Syndrome or Brugada Syndrome
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
TR701-115 ( Other Identifier: TriusRX unique ID )
Not Provided
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Trius Therapeutics LLC
Trius Therapeutics LLC
Not Provided
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
Trius Therapeutics LLC
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP