NCT01442831

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Human ADME	Oral single dose

Timeline

• Start date: 2010-09-09
• Primary completion: 2010-09-22
• Completion: 2010-09-22
• First posted: 2011-09-29
• Last updated: 2019-11-15

Locations

1 site across 1 country: United States