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Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00876655
First Posted: April 7, 2009
Last Update Posted: May 3, 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
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult subjects and to assess the relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule.

Condition Intervention Phase
Healthy Drug: TR-701 di-sodium phosphate salt Drug: TR-701 free acid phosphate 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, Randomized, Single-Dose, 2-Treatment, 2-Sequence, Crossover, Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of TR-701 (Torezolid Phosphate) in Normal Healthy Adults

Resource links provided by NLM:


Further study details as provided by Trius Therapeutics LLC:

Primary Outcome Measures:
  • To evaluate the pharmacokinetics and relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule after single doses in normal healthy adult subjects [ Time Frame: 4 days ]

Secondary Outcome Measures:
  • To determine the safety and tolerability of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult [ Time Frame: 4 days ]

Enrollment: 12
Study Start Date: February 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: free acid
TR-701 free acid phosphate powder in capsule formulation (equivalent to 150 mg TR-700)
Drug: TR-701 free acid phosphate
One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700)
Experimental: di-sodium phosphate salt
One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)
Drug: TR-701 di-sodium phosphate salt
One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)

Detailed Description:

Subjects will receive the following treatments in a crossover design:

Treatment A (Reference): One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature water;

Treatment B (Test): One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature water;

Descriptive statistics will be calculated for PK parameters including Cmax, Tmax, AUC0-t, and AUC0-inf.

  Eligibility

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs;
  • Females will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or agree to use an acceptable form of contraception
  • BMI of 18.5 to 32.0 kg/m2, inclusive

Exclusion Criteria:

  • Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
  • Pregnancy, lactation, 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): NCT00876655


Locations
United States, Texas
Covance Clinical Research Unit
Austin, Texas, United States, 78752
Sponsors and Collaborators
Trius Therapeutics LLC
Investigators
Principal Investigator: David C Carter, 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: NCT00876655     History of Changes
Other Study ID Numbers: 1986-025
TR701-108 ( Other Identifier: TriusRX Unique ID )
First Submitted: April 3, 2009
First Posted: April 7, 2009
Last Update Posted: May 3, 2016
Last Verified: May 2016

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