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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00876655
First received: April 3, 2009
Last updated: October 12, 2011
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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:

MedlinePlus related topics: Dietary Sodium
U.S. FDA Resources

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

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876655

Locations
United States, Texas
Covance Clinical Research Unit
Austin, Texas, United States, 78752
Sponsors and Collaborators
Trius Therapeutics, Inc.
Investigators
Principal Investigator: David C Carter, MD Covance CRU
  More Information

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00876655     History of Changes
Other Study ID Numbers: TR701-108
Study First Received: April 3, 2009
Last Updated: October 12, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sodium phosphate
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013