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

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

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: TR-701 di-sodium phosphate salt

Drug: TR-701 free acid phosphate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00876655

TR701-108 (Other Identifier)

1986-025

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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