NCT04069130

Absorption, Distribution, Metabolism and Excretion of [14C] Labelled BIA 5-1058

An Open-Label Study to Assess the Absorption, Distribution, Metabolism and Excretion, Including the Mass Balance Recovery, Metabolite Profiling and Identification, of [14C] Labelled BIA 5-1058 Following a Single Oral Dose Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to determine the mass balance recovery in expired air, urine and faeces after a single oral dose of 400 mg 14C-labeled BIA 5-1058; to provide plasma, urine and faecal samples for metabolite profiling and structural identification; and determine the routes and rates of elimination of \[14C\]-BIA 5-1058

Detailed description

This is a Phase 1, single-dose, single-centre, single period, open-label, absorption, distribution, metabolism and excretion study in 8 healthy adult male subjects. Subjects will receive a single oral dose of 400 mg \[14C\]-BIA 5-1058, containing not more than (NMT) 4.6 MBq (124 µCi) 14C, as an oral capsule. Subjects will be screened for eligibility to participate in the study between 28 and 2 days before dosing. Eligible subjects will be admitted to the clinical unit on the morning of Day -1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 after an overnight fast of at least 10 hours and will remain resident in the clinic until up to 336 h after dosing (up to Day 15). Blood, urine, faeces and expired air will be collected at predefined time points for mass balance and PK analysis. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of \>90% or if \<1% of the dose administered has been collected in urine, faeces and expired air within 2 separate, consecutive 24 h periods. This may result in the subjects being discharged as a group prior to completion of the planned residency period. Once the discharge criteria or the planned residency period has been achieved, collection of all samples (blood, urine, faeces, and expired air) will be stopped and the subjects will undergo discharge assessments. Subjects who have not met the mass balance discharge criteria on Day 15 will return to the clinical unit for up to five further 24-hour residency periods (Days 21-22 \[±1 day\], 28-29 \[±1 day\], 42-43 \[±2 days\], 56-57 \[±2 days\] and 77-78 \[±3 days\]) to collect blood samples for PK analysis and urine and faeces samples for analysis of total radioactivity. If the parent and metabolite are below the limit of quantification at any of these visits, subsequent return visits may be cancelled. If by Day 78, levels are not below the limit of quantification or if the additional 24 h residency periods are not considered appropriate or necessary, then home collections of urine and/or faeces may be requested at the discretion of the investigator for individual subjects.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	400 mg of BIA 5-1058	1 x 400 mg capsule Oral, Fasted

Timeline

• Start date: 2019-01-22
• Primary completion: 2019-05-02
• Completion: 2019-05-02
• First posted: 2019-08-28
• Last updated: 2020-12-31

Locations

1 site across 1 country: United Kingdom