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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 22, 2014