Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults (SAD/MAD)

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: NCT00671814
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : August 31, 2017
Information provided by (Responsible Party):
Trius Therapeutics LLC

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising oral doses and multiple oral doses of TR-701

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: TR-701 Drug: linezolid Drug: placebo Phase 1

Detailed Description:
This is an evaluation of TR-701 in a double-blind, placebo-controlled, randomized, single (Part A) and multiple (Part B) ascending dose safety, tolerance, and PK when administered as a capsule in normal, healthy adult volunteers. The study will be sequential between Part A and Part B (i.e., not staggered or leap frogged), with slight overlap between last cohort in Part A and first cohort in Part B.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-Blind, Placebo and Active Controlled, Single and Multiple Rising Dose, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults
Actual Study Start Date : January 6, 2008
Actual Primary Completion Date : June 6, 2008
Actual Study Completion Date : June 6, 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Single oral dose of TR-701 given once at 200mg, 400mg, 600mg, 800mg, and 1200mg. Multiple oral doses of TR-701 given once daily for 21 days at 200mg, 300mg and 400mg.
Drug: TR-701
TR-701 will be given as single oral doses in Cohorts 1-5 and as once daily oral doses for 21 days in cohorts 6-8.

Placebo Comparator: 2
Single oral dose of placebo given in cohorts 1-5. Multiple oral doses of placebo given once daily for 21 days in cohorts 6-8 and twice daily for 21 days in cohort 10.
Drug: placebo
Placebo will be given once for cohorts 1-5, once daily for 21 days for cohorts 6-8, and twice daily for 21 days for cohort 10.

Active Comparator: 3
Oral doses of 600mg linezolid given twice daily for 21 days.
Drug: linezolid
Linezolid will be given at 600 mg twice daily for 21 days in cohort 10.

Primary Outcome Measures :
  1. Adverse Event reporting [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. The PK rate and extent of urinary excretion of TR-701 and its microbiologically active moiety, TR-700 [ Time Frame: 21 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • in good health
  • body mass index of 20 to 29.9 kg/m2
  • female subjects must be either postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to use an effective method of birth control

Exclusion Criteria:

  • history or clinical manifestations of any clinically significant disorder
  • history of hypersensitivity or allergies to any drug compound
  • history of stomach or intestinal surgery or resection
  • history of alcoholism or drug addiction within 1 year
  • use of any tobacco-containing or nicotine-containing products within 6 months
  • use of any other medications
  • use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages; or foods or beverages with high levels of tyramine
  • pregnancy, lactation, 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): NCT00671814

United States, Wisconsin
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Trius Therapeutics LLC
Principal Investigator: John Bohn, MD Covance Clinical Research Unit

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Trius Therapeutics LLC Identifier: NCT00671814     History of Changes
Other Study ID Numbers: 1986-016
TR701-101 ( Other Identifier: TriusRX Unique ID )
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by Trius Therapeutics LLC:

Additional relevant MeSH terms:
Torezolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action