A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge

A Phase 1, Blinded, Placebo-Controlled, Crossover TR-701 FA Study of Blood Pressure Response Post-Tyramine Challenge

Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: TR-701 FA with Tyramine; Drug: Placebo-controlled withTyramine

Detailed Description

This is a Phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to determine the effect of 200 mg oral TR-701 FA on SBP response when administered with tyramine in healthy adult male and female volunteers.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Trius Investigator Site 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects between 18 to 45 years of age, inclusive
• Body mass index between 19 kg/m2 and 31 kg/m2, inclusive
• Healthy subjects with no clinically significant abnormalities identified by a detailed medical history,

Exclusion Criteria:

• Systolic blood pressure >130 mmHg or <90 mmHg measured after 10 minutes in the supine position at Screening or at admission to the study center
• Heart rate >90 bpm or <45 bpm measured after 10 minutes in the supine position
• Electrocardiogram (ECG) finding of QTc interval >500 msec, or other clinically significant ECG abnormality at the Screening Visit

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TR-701 FA with Tyramine; TR-701 FA 200 oral with Tyramine	Drug: TR-701 FA with Tyramine; TR-701 FA 200 mg oral and Tyramine; Other Names: Tedizolid Phosphate
Placebo Comparator: Placebo-controlled with Tyramine	Drug: Placebo-controlled withTyramine; Placebo-controlled and Tyramine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure	14 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Flanagan S, Bartizal K, Minassian SL, Fang E, Prokocimer P. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013 Jul;57(7):3060-6. doi: 10.1128/AAC.00431-13. Epub 2013 Apr 22.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimate): February 27, 2012

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Anti-Bacterial Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Sympathomimetics; Adrenergic Uptake Inhibitors; Tedizolid; Tedizolid phosphate; Tyramine
• Other Study ID Numbers: 1986-032; TR701-105 (Other Identifier: TriusRX Unique ID)