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CompletedNCT01461460Updated Dec 5, 2018

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

A Phase 1 interventional study of TR-701 FA 1200 mg and Moxifloxacin 400 mg in Healthy Volunteer, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • volunteer
03

In context

Lead sponsor

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    Moxifloxacin 400 mg

    Drug: Moxifloxacin 400 mg

  • Experimental
    TR-701 FA 1200 mg

    Drug: TR-701 FA 1200 mg

  • Experimental
    TR-701 FA 200 mg plus Placebo

    Drug: TR-701 FA 200 mg plus Placebo

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugTR-701 FA 1200 mg

    6 tablet of T-701 FA

    Also known as: Tedizolid

  • DrugMoxifloxacin 400 mg

    1 tablet 400 mg Moxifloxacin

  • DrugTR-701 FA 200 mg plus Placebo

    1 tablet of TR-701 FA with 5 tablet placebo

    Also known as: Tedizolid

  • DrugPlacebo

    6 placebo tablets

06

What researchers measure

Primary outcomes

  1. QTcF Change from Baseline

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

    Time frame: 24 Hours

07

Study locations

1 site
  • Trius Investigator
    Dallas, Texas 75247, United States
08

References and documents

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. PubMed 27342387 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01461460
Lead sponsor
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Responsible party
Sponsor
First posted
Oct 28, 2011
Start date
Nov 28, 2011
Primary completion
Dec 23, 2011
Completion
Dec 23, 2011
Last update
Dec 5, 2018

Study contacts

Philippe G Prokocimer, MD
study chair · Trius Therapeutics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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

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