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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01577459
First received: April 11, 2012
Last updated: June 6, 2012
Last verified: April 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA

Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: 13 days ] [ Designated as safety issue: No ]
    To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo


Enrollment: 18
Study Start Date: April 2012
Study Completion Date: May 2012
Primary Completion Date: May 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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577459

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

No publications provided by Trius Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01577459     History of Changes
Other Study ID Numbers: TR701-114
Study First Received: April 11, 2012
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 16, 2014