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

NCT01461460 | Completed Phase 1

• 2 other identifiers: 1986-029TR701-115
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

volunteer

Outcome Measures

Primary Outcomes (1)

• QTcF Change from Baseline

  Time-matched, placebo adjusted change from the baseline QTcF (ΔΔQTcF).

  24 Hours

Study Arms (4)

Moxifloxacin 400 mg

ACTIVE COMPARATOR

Drug: Moxifloxacin 400 mg

TR-701 FA 1200 mg

EXPERIMENTAL

Drug: TR-701 FA 1200 mg

TR-701 FA 200 mg plus Placebo

EXPERIMENTAL

Drug: TR-701 FA 200 mg plus Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TR-701 FA 1200 mg DRUG

6 tablet of T-701 FA

Also known as: Tedizolid

TR-701 FA 1200 mg

Moxifloxacin 400 mg DRUG

1 tablet 400 mg Moxifloxacin

Moxifloxacin 400 mg

TR-701 FA 200 mg plus Placebo DRUG

1 tablet of TR-701 FA with 5 tablet placebo

Also known as: Tedizolid

TR-701 FA 200 mg plus Placebo

Placebo DRUG

6 placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

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

Study Sites (1)

Trius Investigator

Dallas, Texas, 75247, United States

Location

Related Publications (1)

• 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.

  PMID: 27342387 BACKGROUND

MeSH Terms

Interventions

tedizolid; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Philippe G Prokocimer, MD

  Trius Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: October 28, 2011
• Study Start: November 28, 2011
• Primary Completion: December 23, 2011
• Study Completion: December 23, 2011
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

US (1)