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

NCT ID: NCT00876655

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2009-03-31

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

free acid

TR-701 free acid phosphate powder in capsule formulation (equivalent to 150 mg TR-700)

Group Type: EXPERIMENTAL

TR-701 free acid phosphate

Intervention Type: DRUG

One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700)

di-sodium phosphate salt

One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)

Group Type: EXPERIMENTAL

TR-701 di-sodium phosphate salt

Intervention Type: DRUG

One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)

Interventions

TR-701 di-sodium phosphate salt

One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)

Intervention Type: DRUG

TR-701 free acid phosphate

One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David C Carter, MD

Role: PRINCIPAL_INVESTIGATOR

Covance CRU

Locations

Covance Clinical Research Unit

Austin, Texas, United States

Countries

United States

References

Flanagan SD, Bien PA, Munoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7.

Reference Type: DERIVED

PMID: 23926058 (View on PubMed)

Other Identifiers

TR701-108

Identifier Type: OTHER

Identifier Source: secondary_id

1986-025

Identifier Type: -

Identifier Source: org_study_id