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Completed

NCT Number: NCT01461460

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

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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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Trius Investigator

Dallas, Texas, 75247, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TR-701 FA 1200 mg

Drug

6 tablet of T-701 FA

Other names: Tedizolid

Moxifloxacin 400 mg

Drug

1 tablet 400 mg Moxifloxacin

TR-701 FA 200 mg plus Placebo

Drug

1 tablet of TR-701 FA with 5 tablet placebo

Other names: Tedizolid

Placebo

Drug

6 placebo tablets

Primary outcomes

  1. QTcF Change from Baseline

    Time frame: 24 Hours

    Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).

Sponsors and collaborators

Lead sponsor

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study title

A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2011
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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