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

Sponsor
Trius Therapeutics LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01577459
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
1.7
Actual Duration (Months)
10.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: TR-701 FA with PSE
  • Other: TR-701 FA Placebo with PSE
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
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
Actual Study Start Date :
Apr 23, 2012
Actual Primary Completion Date :
Jun 15, 2012
Actual Study Completion Date :
Jun 15, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Systolic Blood Pressure [13 days]

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

    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 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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Trius Therapeutics LLC
    ClinicalTrials.gov Identifier:
    NCT01577459
    Other Study ID Numbers:
    • 1986-033
    • TR701-114
    First Posted:
    Apr 13, 2012
    Last Update Posted:
    Aug 21, 2018
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Tedizolid phosphate
    Tedizolid

    Study Results

    No Results Posted as of Aug 21, 2018