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

This study has been completed.
Information provided by (Responsible Party):
Trius Therapeutics LLC Identifier:
First received: June 6, 2011
Last updated: April 27, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Healthy Drug: Human ADME Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-TR-701 in Healthy Adult Male Subjects

Further study details as provided by Trius Therapeutics LLC:

Primary Outcome Measures:
  • To describe the single dose plasma PK of TR-700, the microbiologically active molecule [ Time Frame: pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, then daily up to 312 hours post dose ]
    To describe the single dose pharmacokinetics (Cmax, Tmax, AUC, t 1/2, CL/F) of total radioactivity in plasma, whole blood, urine and feces following oral (PO) administration of [14C] TR 701 in healthy adult male subjects

Enrollment: 6
Study Start Date: September 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human ADME Drug: Human ADME
Oral single dose

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. 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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01442831

United States, Wisconsin
Trius Investigator Site 001
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Trius Therapeutics LLC
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
  More Information

Responsible Party: Trius Therapeutics LLC Identifier: NCT01442831     History of Changes
Other Study ID Numbers: 1986-024
TR701-106 ( Other Identifier: TriusRX unique Id )
Study First Received: June 6, 2011
Last Updated: April 27, 2016

Keywords provided by Trius Therapeutics LLC:
metabolic profile of TR-700 in plasma urine processed this record on July 26, 2017