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Food Effects of Single Oral Dose of 600mg TR-701

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671359
First Posted: May 5, 2008
Last Update Posted: April 29, 2016
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
This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.

Condition Intervention Phase
Healthy Drug: TR-701 600mg Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Single-Dose, Two-Treatment, Randomized, Two-Way Crossover, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults in the Fed and Fasted State

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics LLC:

Primary Outcome Measures:
  • To determine the safety and tolerability of TR-701 600mg given as a single oral dose. [ Time Frame: 4 days ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetics of single doses of TR-701 and its microbiologically active moiety, TR-700, in healthy adult volunteers in the fed and fasted state [ Time Frame: 4 days ]

Enrollment: 12
Study Start Date: April 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: after fast
Administration of a single oral dose of 600mg TR-701 to subjects in the fasted state.
Drug: TR-701 600mg
TR-701 600mg
Experimental: After high fat food
Administration of a single oral dose of 600mg TR-701 to subjects in the fed state.
Drug: TR-701 600mg
TR-701 600mg

Detailed Description:

Subjects will receive the following treatments in a crossover design:

Treatment A: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water after at least a 10-hour fast.

Treatment B: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water following a high-fat meal preceded by at least a 10-hour fast.

Descriptive statistics will be calculated for PK parameters where available, including Cmax, Tmax, AUC0-t, and AUC0-inf. Minimum, maximum, mean, and median values will be determined and standard deviations will be calculated. Where data are available, food effect will be examined between test (fed state) and reference (fasted state) groups.

  Eligibility

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
Criteria

Inclusion Criteria:

  • BMI of 20 to 29.9 kg/m2
  • Females must be either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or agree to use an acceptable method of birth control

Exclusion Criteria:

  • history or clinical manifestations of any clinically significant medical 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
  • pregnancy, lactation, or breastfeeding
  • 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
  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): NCT00671359


Locations
United States, California
Covance CRU
San Diego, California, United States, 92123
Sponsors and Collaborators
Trius Therapeutics LLC
Investigators
Principal Investigator: Michael Berry, MD Covance CRU
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT00671359     History of Changes
Other Study ID Numbers: 1986-023
TR701-103 ( Other Identifier: TriusRX Unique ID )
First Submitted: May 1, 2008
First Posted: May 5, 2008
Last Update Posted: April 29, 2016
Last Verified: April 2016

Keywords provided by Trius Therapeutics LLC:
Food effects

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