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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
  Purpose

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


Condition Intervention Phase
Healthy Volunteer
 Drug: TR-701 FA 1200 mg
Drug: Moxifloxacin 400 mg
Drug: TR-701 FA 200 mg plus Placebo
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:
  • QTcF Change from Baseline [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).


Enrollment: 48
Study Start Date: November 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Moxifloxacin 400 mg
Not applicable
 Drug: Moxifloxacin 400 mg
1 tablet 400 mg Moxifloxacin
Experimental: TR-701 FA 1200 mg
Not applicable
 Drug: TR-701 FA 1200 mg
6 tablet of T-701 FA
Other Name: Tedizolid
Experimental: TR-701 FA 200 mg plus Placebo
Not applicable
 Drug: TR-701 FA 200 mg plus Placebo
1 tablet of TR-701 FA with 5 tablet placebo
Other Name: Tedizolid
Placebo Comparator: Placebo
Not applicable
 Drug: Placebo
6 placebo tablets

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461460

Locations
United States, Texas
Trius Investigator
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
  More Information

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01461460     History of Changes
Other Study ID Numbers: TR701-115
Study First Received: October 26, 2011
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
 Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013