This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of
TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.
Subjects will receive the following treatments in a crossover design:
Treatment A: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL
room temperature tap water after at least a 10-hour fast.
Treatment B: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL
room temperature tap water following a high-fat meal preceded by at least a 10-hour fast.
Descriptive statistics will be calculated for PK parameters where available, including Cmax,
Tmax, AUC0-t, and AUC0-inf. Minimum, maximum, mean, and median values will be determined and
standard deviations will be calculated. Where data are available, food effect will be
examined between test (fed state) and reference (fasted state) groups.
- BMI of 20 to 29.9 kg/m2
- Females must be either postmenopausal for at least 1 year, surgically sterile for at
least 90 days, or agree to use an acceptable method of birth control
- history or clinical manifestations of any clinically significant medical disorder
- history of hypersensitivity or allergies to any drug compound
- history of stomach or intestinal surgery or resection
- history of alcoholism or drug addiction within 1 year
- pregnancy, lactation, or breastfeeding
- use of any tobacco-containing or nicotine-containing products within 6 months
- use of any other medications
- use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or
beverages; or foods or beverages with high levels of tyramine