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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-28

Study Completion Date

2011-12-23

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.

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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.

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Moxifloxacin 400 mg

Group Type ACTIVE_COMPARATOR

Moxifloxacin 400 mg

Intervention Type DRUG

1 tablet 400 mg Moxifloxacin

TR-701 FA 1200 mg

Group Type EXPERIMENTAL

TR-701 FA 1200 mg

Intervention Type DRUG

6 tablet of T-701 FA

TR-701 FA 200 mg plus Placebo

Group Type EXPERIMENTAL

TR-701 FA 200 mg plus Placebo

Intervention Type DRUG

1 tablet of TR-701 FA with 5 tablet placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

6 placebo tablets

Interventions

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TR-701 FA 1200 mg

6 tablet of T-701 FA

Intervention Type DRUG

Moxifloxacin 400 mg

1 tablet 400 mg Moxifloxacin

Intervention Type DRUG

TR-701 FA 200 mg plus Placebo

1 tablet of TR-701 FA with 5 tablet placebo

Intervention Type DRUG

Placebo

6 placebo tablets

Intervention Type DRUG

Other Intervention Names

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Tedizolid Tedizolid

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes