Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156

Parkinson Disease Clinical Trial

Official title: An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of Carbon-14 BIA 28-6156 in Healthy Male Subjects

Status Completed

Clinical Trial Summary

The study is designed to determine the absorption, distribution, metabolism and elimination (ADME) of BIA 28-6156 in humans, further explore the PK of BIA 28-6156, evaluate the extent of distribution of total radioactivity into blood cells, provide additional safety and tolerability information and collect samples for metabolite profiling and structural identification.

Clinical Trial Description

This is an open-label, single-dose, single period study in healthy male subjects. It is planned to enroll 6 subjects. All subjects will receive a single oral dose Carbon-14 BIA 28-6156. Blood samples will be collected at regular intervals for PK analysis, mass balance and metabolite profiling and identification from pre-dose up to 240 h post-dose. Urine and faecal samples will be collected at regular intervals for mass balance and metabolite profiling and identification from pre-dose until the mass balance criteria have been met. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT05220072
• Study type: Interventional
• Source: Bial R&D Investments, S.A.
• Status: Completed
• Phase: Phase 1
• Start date: August 28, 2021
• Completion date: October 16, 2021