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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01461460
First received: October 26, 2011
Last updated: June 6, 2012
Last verified: October 2011
History of Changes

October 26, 2011
June 6, 2012
November 2011
December 2011   (final data collection date for primary outcome measure)
QTcF Change from Baseline [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).
Same as current
Complete list of historical versions of study NCT01461460 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram

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

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Healthy Volunteer
  • Drug: TR-701 FA 1200 mg
    6 tablet of T-701 FA
    Other Name: Tedizolid
  • Drug: Moxifloxacin 400 mg
    1 tablet 400 mg Moxifloxacin
  • Drug: TR-701 FA 200 mg plus Placebo
    1 tablet of TR-701 FA with 5 tablet placebo
    Other Name: Tedizolid
  • Drug: Placebo
    6 placebo tablets
  • Active Comparator: Moxifloxacin 400 mg
    Not applicable
    Intervention: Drug: Moxifloxacin 400 mg
  • Experimental: TR-701 FA 1200 mg
    Not applicable
    Intervention: Drug: TR-701 FA 1200 mg
  • Experimental: TR-701 FA 200 mg plus Placebo
    Not applicable
    Intervention: Drug: TR-701 FA 200 mg plus Placebo
  • Placebo Comparator: Placebo
    Not applicable
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01461460
TR701-115
No
Trius Therapeutics, Inc.
Trius Therapeutics, Inc.
Not Provided
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
Trius Therapeutics, Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP