NCT01702194

TD-1211 IV/Oral Mass Balance Study

A Single-Dose, Fixed-Sequence, Two-Period, Two-Treatment Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-1211 Following an Intravenous Infusion and an Oral Dose of [14C]TD-1211 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine TD-1211 is processed by the body.

Detailed description

This study will provide information regarding the metabolic pathway of TD 1211, the need for evaluation of potential drug-drug interactions, the need for studies in special populations and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of TD 1211, providing further quantitative information on the disposition of TD 1211. The results from this study will allow a more comprehensive comparison between animal and human routes of elimination and metabolic profiles of TD 1211.

Conditions

• OIC

Interventions

Type	Name	Description
DRUG	TD-1211 IV [C14]
DRUG	TD-1211 PO [C14]

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2012-10-05
• Last updated: 2021-01-20

Locations

1 site across 1 country: United States