NCT03014375

Absorption, Distribution, Metabolism and Excretion of [14C]- Labeled BIA 5-453 and Metabolites

An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 5-453 and Metabolites Following a Single-dose Oral Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to: To determine the rate and routes of excretion of BIA 5-453 and the mass balance in urine and faeces

Detailed description

Monocentre, open, non-placebo-controlled, single-group, single-dose study Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) will be conducted before and after the study, adverse events will be monitored throughout the study. Subjects should be hospitalized the day before the administration until 264 hours thereafter.

Conditions

• Hypertension
• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	BIA-5-453	Each subject will receive a single oral dose of 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 (600 mg).

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2017-01-09
• Last updated: 2017-01-09

Locations

1 site across 1 country: Switzerland