NCT05220072

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Bial R&D Investments, S.A. · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Carbon-14 BIA 28-6156	Carbon-14 BIA 28-6156 60 mg, containing NMT 3.7 MBq Carbon-14

Timeline

• Start date: 2021-08-28
• Primary completion: 2021-10-16
• Completion: 2021-10-16
• First posted: 2022-02-02
• Last updated: 2025-05-28

Locations

1 site across 1 country: United Kingdom