Status:
COMPLETED
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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....
Eligibility Criteria
Inclusion
- Males, between 18 and 50 years of age, inclusive.
- Body mass index (BMI) of 20 kg/m2 to 29.9 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs.
Exclusion
- 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).
- History of an abnormal ECG that is clinically significant in the opinion of the Investigator.
- History of hypersensitivity, intolerance, or allergy to antibiotics of the oxazolidinone class, to any ingredient of the formulation.
Key Trial Info
Start Date :
September 9 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01442831
Start Date
September 9 2010
End Date
September 22 2010
Last Update
November 15 2019
Active Locations (1)
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1
Trius Investigator Site 001
Madison, Wisconsin, United States, 53704