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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00671359
First received: May 1, 2008
Last updated: October 12, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

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

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

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671359

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

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00671359     History of Changes
Other Study ID Numbers: TR701-103
Study First Received: May 1, 2008
Last Updated: October 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:
Food effects

ClinicalTrials.gov processed this record on May 23, 2013