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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Moxifloxacin 400 mg; Drug: TR-701 FA 1200 mg; Drug: TR-701 FA 200 mg plus Placebo; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Trius Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 6 placebo tablets
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Trius Therapeutics LLC
• Investigators: Study Chair: Philippe G Prokocimer, MD, Trius Therapeutics

Publications and helpful links

General Publications

• Flanagan S, Litwin J, Fang E, Prokocimer P. Effects of therapeutic and supratherapeutic doses of oral tedizolid phosphate on cardiac repolarisation in healthy volunteers: a randomised controlled study. Int J Antimicrob Agents. 2016 Jul;48(1):33-40. doi: 10.1016/j.ijantimicag.2015.12.015. Epub 2016 Jun 2.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2011
• Primary Completion (Actual): December 23, 2011
• Study Completion (Actual): December 23, 2011

Study Registration Dates

• First Submitted: October 26, 2011
• First Submitted That Met QC Criteria: October 27, 2011
• First Posted (Estimate): October 28, 2011

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: volunteer
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Moxifloxacin; Oxazolidinones; Tedizolid; Tedizolid phosphate
• Other Study ID Numbers: 1986-029; TR701-115 (Other Identifier: TriusRX unique ID)