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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01461460
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics LLC

Tracking Information
First Submitted Date  ICMJE October 26, 2011
First Posted Date  ICMJE October 28, 2011
Last Update Posted Date December 5, 2018
Actual Study Start Date  ICMJE November 28, 2011
Actual Primary Completion Date December 23, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
QTcF Change from Baseline [ Time Frame: 24 Hours ]
Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
Official Title  ICMJE A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram
Brief Summary The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2011)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 23, 2011
Actual Primary Completion Date December 23, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461460
Other Study ID Numbers  ICMJE 1986-029
TR701-115 ( Other Identifier: TriusRX unique ID )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Trius Therapeutics LLC
Study Sponsor  ICMJE Trius Therapeutics LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
PRS Account Trius Therapeutics LLC
Verification Date December 2018

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