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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01539473
First received: February 21, 2012
Last updated: June 12, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
 Drug: TR-701 FA with Tyramine
Drug: Placebo-controlled withTyramine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Phase 1, Blinded, Placebo-Controlled, Crossover TR-701 FA Study of Blood Pressure Response Post-Tyramine Challenge

Resource links provided by NLM:

Drug Information available for: Tyramine
U.S. FDA Resources

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

Primary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure


Enrollment: 30
Study Start Date: February 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 Tyramine
TR-701 FA 200 oral with Tyramine
 Drug: TR-701 FA with Tyramine
TR-701 FA 200 mg oral and Tyramine
Other Name: Tedizolid Phosphate
Placebo Comparator: Placebo-controlled with Tyramine
Placebo-controlled with Tyramine
 Drug: Placebo-controlled withTyramine
Placebo-controlled and Tyramine

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.

  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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539473

Locations
United States, Indiana
Trius Investigator Site 001
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
  More Information

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01539473     History of Changes
Other Study ID Numbers: TR701-105
Study First Received: February 21, 2012
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tyramine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013