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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461460
• Other study ID #: 1986-029
• Secondary ID: TR701-115
• Status: Completed
• Phase: Phase 1
• Start date: November 28, 2011
• Est. completion date: December 23, 2011

Study information

• Verified date: December 2018
• Source: Trius Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 23, 2011
• Est. primary completion date: December 23, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• TR-701 FA 1200 mg
6 tablet of T-701 FA
• Moxifloxacin 400 mg
1 tablet 400 mg Moxifloxacin
• TR-701 FA 200 mg plus Placebo
1 tablet of TR-701 FA with 5 tablet placebo
• Placebo
6 placebo tablets

Locations

Country	Name	City	State
United States	Trius Investigator	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Trius Therapeutics LLC

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTcF Change from Baseline	Time-matched, placebo adjusted change from the baseline QTcF (??QTcF).	24 Hours