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

Sponsor

Trius Therapeutics LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01461460

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

58.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Other

Official Title:

A Phase 1 Blinded, Placebo-controlled Crossover Study to Evaluate the Effects of Oral TR 701 Free Acid on the Electrocardiogram

Actual Study Start Date :

Nov 28, 2011

Actual Primary Completion Date :

Dec 23, 2011

Actual Study Completion Date :

Dec 23, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Moxifloxacin 400 mg	Drug: Moxifloxacin 400 mg 1 tablet 400 mg Moxifloxacin
Experimental: TR-701 FA 1200 mg	Drug: TR-701 FA 1200 mg 6 tablet of T-701 FA Other Names: Tedizolid
Experimental: TR-701 FA 200 mg plus Placebo	Drug: TR-701 FA 200 mg plus Placebo 1 tablet of TR-701 FA with 5 tablet placebo Other Names: Tedizolid
Placebo Comparator: Placebo	Drug: Placebo 6 placebo tablets

Outcome Measures

Primary Outcome Measures

QTcF Change from Baseline [24 Hours]
Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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