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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01442831
First Posted: September 29, 2011
Last Update Posted: April 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Trius Therapeutics LLC
  Purpose
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: None (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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442831


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

Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01442831     History of Changes
Other Study ID Numbers: 1986-024
TR701-106 ( Other Identifier: TriusRX unique Id )
First Submitted: June 6, 2011
First Posted: September 29, 2011
Last Update Posted: April 29, 2016
Last Verified: April 2016

Keywords provided by Trius Therapeutics LLC:
metabolic profile of TR-700 in plasma urine