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Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects

Healthy Clinical Trial

Official title:
A Phase I, Two-part, Open-label, Non-randomised Study to Investigate the Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects

Clinical Trial Summary

The primary objectives of this study are:

- To determine the mass balance recovery (expired air, urine and faeces) and route and rate of elimination of 14C-Debio 1450.

- To determine the metabolic profile of 14C-Debio 1450 in whole blood, plasma, urine and faeces.

- To determine the pharmacokinetics of total radioactivity and of Debio 1450 (prodrug) and Debio 1452 (active moiety) in plasma and urine.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02595203
Study type Interventional
Source Debiopharm International SA
Contact
Status Completed
Phase Phase 1
Start date November 2015
Completion date December 2015
View Details
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