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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01442831

Run by

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

People needed

6

Starts

2010-09-09

Expected to finish

2010-09-22

Last updated by the study team

2019-11-15

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Trius Investigator Site 001 — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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