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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01577459
First Posted: April 13, 2012
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Trius Therapeutics LLC
  Purpose
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.

Condition Intervention Phase
Healthy Subjects Drug: TR-701 FA with PSE Other: TR-701 FA Placebo with PSE Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics LLC:

Primary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: 13 days ]
    To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo


Enrollment: 18
Actual Study Start Date: April 23, 2012
Study Completion Date: June 15, 2012
Primary Completion Date: June 15, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TR-701 FA with PSE
TR-701 FA 200 mg oral with PSE
Drug: TR-701 FA with PSE
TR-701 FA Oral 200 mg oral with PSE
Other Name: Tedizolid Phosphate
Placebo Comparator: TR-701 FA Placebo with PSE
TR-701 FA Placebo 200 mg oral with PSE
Other: TR-701 FA Placebo with PSE
TR-701 FA Placebo Oral 200 mg with PSE

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577459


Locations
United States, Kansas
Trius Investigator Site 001
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Trius Therapeutics LLC
Investigators
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01577459     History of Changes
Other Study ID Numbers: 1986-033
TR701-114 ( Other Identifier: TriusRX Unique ID )
First Submitted: April 11, 2012
First Posted: April 13, 2012
Last Update Posted: October 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Torezolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents