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Completed

NCT Number: NCT01442831

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Trius Investigator Site 001

Madison, Wisconsin, 53704, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Human ADME

Drug

Oral single dose

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-TR-701 in Healthy Adult Male Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 29, 2011
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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