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

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. Identifier: NCT01496677
Recruitment Status : Completed
First Posted : December 21, 2011
Last Update Posted : October 6, 2017
Information provided by (Responsible Party):
Trius Therapeutics LLC

Brief Summary:
To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: TR-701 FA 200 mg Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Actual Study Start Date : January 17, 2012
Actual Primary Completion Date : February 28, 2012
Actual Study Completion Date : February 28, 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01496677

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Trius Therapeutics LLC Identifier: NCT01496677     History of Changes
Other Study ID Numbers: 1986-028
TR701-109 ( Other Identifier: TriusRX Unique ID )
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Keywords provided by Trius Therapeutics LLC:
Additional relevant MeSH terms:
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Tedizolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents