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

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

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: TR-701 FA 200 mg plus Placebo; Drug: Placebo; Drug: TR-701 FA 1200 mg; Drug: Moxifloxacin 400 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01461460

TR701-115 (Other Identifier)

1986-029

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 4 patient groups, including a placebo group

Moxifloxacin 400 mg

Active Comparator group

Treatment:

Drug: Moxifloxacin 400 mg

TR-701 FA 1200 mg

Experimental group

Treatment:

Drug: TR-701 FA 1200 mg

TR-701 FA 200 mg plus Placebo

Experimental group

Treatment:

Drug: TR-701 FA 200 mg plus Placebo

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo