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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01461460

Enrollment

Registered

2011-10-28

Start date

2011-11-28

Completion date

2011-12-23

Last updated

2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

volunteer

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 healthy subjects.

Interventions

DRUGTR-701 FA 1200 mg

6 tablet of T-701 FA

DRUGMoxifloxacin 400 mg

1 tablet 400 mg Moxifloxacin

DRUGTR-701 FA 200 mg plus Placebo

1 tablet of TR-701 FA with 5 tablet placebo

DRUGPlacebo

6 placebo tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
QTcF Change from Baseline	24 Hours	Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026