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NCT Number: NCT01577459

A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response

This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers.

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Trius Investigator Site 001

Overland Park, Kansas, 66212, United States

About this study

Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701 FA once daily for 5 days during each treatment period, with a 2 day washout between periods (72 hours between doses). On Study Day 5 of each treatment period, subjects will also receive oral 60 mg PSE.

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 and 45 years of age, inclusive
  • Healthy males and females with no clinically significant abnormalities identified by a detailed medical history
  • Body mass index ≥ 19.0 kg/m2 and ≤ 31.0 kg/m2

Exclusion criteria

  • Systolic blood pressure > 130 mmHg or < 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
  • Diastolic blood pressure > 90 mmHg or < 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
  • Heart rate > 90 bpm or < 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day
  • Known allergy or hypersensitivity to PSE

Treatment and study plan

TR-701 FA with PSE

Drug

TR-701 FA Oral 200 mg oral with PSE

Other names: Tedizolid Phosphate

TR-701 FA Placebo with PSE

Other

TR-701 FA Placebo Oral 200 mg with PSE

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 13 days

    To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo

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 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2012
Registry last updated
Aug 21, 2018

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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