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

Sponsor
Trius Therapeutics LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01539473
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
3
Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: TR-701 FA with Tyramine
  • Drug: Placebo-controlled withTyramine
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Official Title:
A Phase 1, Blinded, Placebo-Controlled, Crossover TR-701 FA Study of Blood Pressure Response Post-Tyramine Challenge
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

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

    Placebo-controlled with Tyramine

    Drug: Placebo-controlled withTyramine
    Placebo-controlled and Tyramine

    Outcome Measures

    Primary Outcome Measures

    1. Systolic Blood Pressure [14 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Trius Investigator Site 001 Evansville Indiana United States 47710

    Sponsors and Collaborators

    • Trius Therapeutics LLC

    Investigators

    • Study Chair: Philippe G Prokocimer, MD, Trius Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Trius Therapeutics LLC
    ClinicalTrials.gov Identifier:
    NCT01539473
    Other Study ID Numbers:
    • 1986-032
    • TR701-105
    First Posted:
    Feb 27, 2012
    Last Update Posted:
    May 3, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Tedizolid phosphate
    Tedizolid
    Tyramine

    Study Results

    No Results Posted as of May 3, 2016