Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 10/27/2018 |
Start Date: | September 9, 2010 |
End Date: | September 22, 2010 |
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.
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.
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.
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