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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01442831
First received: June 6, 2011
Last updated: October 12, 2011
Last verified: October 2011
  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
Endpoint Classification: Safety Study
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, Inc.:

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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442831

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

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01442831     History of Changes
Other Study ID Numbers: TR701-106
Study First Received: June 6, 2011
Last Updated: October 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Trius Therapeutics, Inc.:
metabolic profile of TR-700 in plasma urine

ClinicalTrials.gov processed this record on August 01, 2014