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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Trius Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 22, 2014