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Pharmacokinetics, Safety, and Tolerability of TR-701 Free Acid (FA) in Elderly Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496677
First Posted: December 21, 2011
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Trius Therapeutics LLC
  Purpose
To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects

Condition Intervention Phase
Healthy Subjects Drug: TR-701 FA 200 mg Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1 Open-Label Study With Oral TR-701 Free Acid to Assess Pharmacokinetics, Safety, and Tolerability in Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics LLC:

Primary Outcome Measures:
  • Compare PK profile of TR-700 FA in elderly subjects versus younger control subjects [ Time Frame: 28 days ]

Enrollment: 28
Actual Study Start Date: January 17, 2012
Study Completion Date: February 28, 2012
Primary Completion Date: February 28, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elderly subjects (65 or older) Drug: TR-701 FA 200 mg
Single oral tablet of TR-701 FA to elderly subjects
Experimental: Younger adults (18-45 years old) Drug: TR-701 FA 200 mg
Single oral tablet of TR-701 FA to younger group (18-45 years old)

Detailed Description:
This is an open-label Phase 1 study of a single oral tablet of TR-701 FA 200 mg to compare the TR-700 PK profile in elderly subjects (age 65 years and older, with at least 5 subjects 75 years old or older) and younger control subjects (age 18 to 45 years).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects in the following groups: An elderly subject at least 65 years of age. At least 5 subjects must be at least 75 years of age OR A matched-control subject between 18 and 45 years of age, inclusive
  • BMI ≥18.0 kg/m2 and ≤35.0 kg/m2

Elderly Group

  • Medical history, physical examination, and laboratory results consistent with stable health (as determined by the Investigator)

Control Group

  • Medically stable with no clinically significant abnormalities

Exclusion Criteria:

  • Significant, uncontrolled, or life-threatening condition or organ or system condition or disease (eg, impaired cognitive status, respiratory insufficiency, advanced malnutrition)
  • Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody test result
  • Previous inclusion in a TR-701 FA or TR-701 clinical study
  • ECG finding of QTc interval >500 msec, or other clinically significant ECG abnormality at Screening
  • Female subjects whom are pregnant, lactating or breastfeeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496677


Locations
United States, Florida
Trius Investigator Site 001
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Trius Therapeutics LLC
Investigators
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
  More Information

Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01496677     History of Changes
Other Study ID Numbers: 1986-028
TR701-109 ( Other Identifier: TriusRX Unique ID )
First Submitted: December 19, 2011
First Posted: December 21, 2011
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by Trius Therapeutics LLC:
volunteer

Additional relevant MeSH terms:
Torezolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents