Status:
COMPLETED
A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the effects of oral TR-701 free acid (FA) versus placebo on QTcF.
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 he...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01461460
Start Date
November 28 2011
End Date
December 23 2011
Last Update
December 5 2018
Active Locations (1)
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1
Trius Investigator
Dallas, Texas, United States, 75247