The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus
placebo on QTcF.
Drug: TR-701 FA 1200 mg
Drug: Moxifloxacin 400 mg
Drug: TR-701 FA 200 mg plus Placebo
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Locations near you
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Full eligibility criteria for NCT01461460
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01461460
United States (1)
Dallas, Texas, United States, 75247
View full eligibility
Tris trial is registered with FDA with number: NCT01461460. The sponsor of the trial is Trius Therapeutics LLC and it is looking for 48 volunteers for the current phase.
Official trial title: A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram
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