Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate - Full Text View

Sponsored by:	Trius Therapeutics, Inc.
Information provided by:	Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00876655

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 Subjects	Drug: TR-701 di-sodium phosphate salt Drug: TR-701 free acid phosphate	Phase I

MedlinePlus related topics: Dietary Sodium

Drug Information available for: Sodium phosphate, dibasic Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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

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
1: Experimental One 182 mg capsule of 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)
2: Experimental 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 ( Paul Bien, Senior Director Clinical Operations/Project Management )
Study ID Numbers:	TR701-108
Study First Received:	April 3, 2009
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00876655 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Laxatives
Sodium phosphate
Cathartics
Healthy

Additional relevant MeSH terms:

Sodium phosphate
Therapeutic Uses
Gastrointestinal Agents
Cathartics
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009