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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

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

Key facts

Study ID

NCT01461460

Run by

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

People needed

48

Starts

2011-11-28

Expected to finish

2011-12-23

Last updated by the study team

2018-12-05

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Trius Investigator — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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