NCT02595203

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: Male
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[14C-pos 1]-Debio 1450 BES Solution	A solution containing Debio 1450 bis ethanolamine salt (BES) radiolabelled with carbon-14 (14C) at position 1
DRUG	[14C-pos 25]-Debio 1450 BES Solution	A solution containing Debio 1450 BES radiolabelled with carbon-14 (14C) at position 25

Timeline

• Start date: 2015-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-11-03
• Last updated: 2016-01-18

Locations

1 site across 1 country: United Kingdom