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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: TR-701 FA 1200 mg
* Drug: Moxifloxacin 400 mg
* Drug: TR-701 FA 200 mg plus Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moxifloxacin 400 mg<br> | Drug: Moxifloxacin 400 mg<br>* 1 tablet 400 mg Moxifloxacin<br>|
| Experimental: TR-701 FA 1200 mg<br> | Drug: TR-701 FA 1200 mg<br>* 6 tablet of T-701 FA<br>* Other names: Tedizolid;|
| Experimental: TR-701 FA 200 mg plus Placebo<br> | Drug: TR-701 FA 200 mg plus Placebo<br>* 1 tablet of TR-701 FA with 5 tablet placebo<br>* Other names: Tedizolid;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 6 placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTcF Change from Baseline | Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF). | 24 Hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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volunteer