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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

Brief Summary:
The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: TR-701 FA 1200 mg Drug: Moxifloxacin 400 mg Drug: TR-701 FA 200 mg plus Placebo Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram
Actual Study Start Date : November 28, 2011
Actual Primary Completion Date : December 23, 2011
Actual Study Completion Date : December 23, 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Moxifloxacin 400 mg Drug: Moxifloxacin 400 mg
1 tablet 400 mg Moxifloxacin

Experimental: TR-701 FA 1200 mg Drug: TR-701 FA 1200 mg
6 tablet of T-701 FA
Other Name: Tedizolid

Experimental: TR-701 FA 200 mg plus Placebo Drug: TR-701 FA 200 mg plus Placebo
1 tablet of TR-701 FA with 5 tablet placebo
Other Name: Tedizolid

Placebo Comparator: Placebo Drug: Placebo
6 placebo tablets




Primary Outcome Measures :
  1. QTcF Change from Baseline [ Time Frame: 24 Hours ]
    Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461460


Locations
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United States, Texas
Trius Investigator
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Trius Therapeutics LLC
Investigators
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Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
Publications:
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Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01461460    
Other Study ID Numbers: 1986-029
TR701-115 ( Other Identifier: TriusRX unique ID )
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Keywords provided by Trius Therapeutics LLC:
volunteer
Additional relevant MeSH terms:
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Moxifloxacin
Tedizolid phosphate
Tedizolid
Oxazolidinones
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Synthesis Inhibitors