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Completed

NCT Number: NCT01539473

A Phase 1 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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Trius Investigator Site 001

Evansville, Indiana, 47710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TR-701 FA with Tyramine

Drug

TR-701 FA 200 mg oral and Tyramine

Other names: Tedizolid Phosphate

Placebo-controlled withTyramine

Drug

Placebo-controlled and Tyramine

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 14 days

    To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 27, 2012
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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