Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects

An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-TR-701 in Healthy Adult Male Subjects

The purpose of this study is to describe the single dose pharmacokinetics of total radioactivity in plasma and whole blood following PO administration of [14C] TR-701 in healthy adult male subjects.

This study will be an open-label, single-dose study of the absorption, metabolism, and excretion of 200 mg [14C]-TR-701 (approximately 100 μCi) administered orally following at least an 8-hour fast. Subjects will receive a single dose of 200 mg [14C] TR 701 (approximately 100 μCi) administered as an oral solution.

The dose will be administered following at least an 8-hour fast and followed by a 4-hour fast from food, not including water.

Inclusion Criteria:

1. Males, between 18 and 50 years of age, inclusive.
2. Body mass index (BMI) of 20 kg/m2 to 29.9 kg/m2, inclusive.
3. In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs.

Exclusion Criteria:

1. Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator and Sponsor).
2. History of an abnormal ECG that is clinically significant in the opinion of the Investigator.
3. History of hypersensitivity, intolerance, or allergy to antibiotics of the oxazolidinone class, to any ingredient of the formulation.