NCT04991181

Absorption, Distribution, Metabolism and Excretion of BIA 5-1058

An Open-label Study to Assess the Absorption, Distribution, Metabolism and Excretion, Including the Mass Balance, of [14C] Labeled BIA 5-1058 and Metabolites Following a Single Oral Dose Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

the purpose of this study is: * to determine the rate and routes of excretion of BIA 5-1058 and the mass balance in urine, feces and exhaled air, after a single oral dose of 400 mg 14C labeled BIA 5 1058 containing 3.7 Megabecquerel (MBq) of radiocarbon; * to determine the pharmacokinetics (PK) of total radioactivity (TRA) in plasma and whole blood and to assess the blood-to-plasma ratio; * to determine the PK of BIA 5-1058 and its metabolites in plasma.

Detailed description

This was a Phase 1, single-center, open-label, absorption, distribution, metabolism, and excretion study in 8 healthy adult male subjects. Subjects received a single oral dose of 400 mg BIA 5-1058, containing approximately 3.7 MBq (0.08 milliSievert \[mSv\]) of 14C-BIA 5-1058 as oral capsules. Screening was between Day -21 and Day -2 and confinement period was of one period in the clinic involving drug administration on Day 1, with admission on Day 1 and discharge on Day 15 (336 hours post-dose).

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	400 mg BIA 5-1058	Capsules, oral administered to subjects between 08:00 and 09:00 hours in the morning of Day 1after an overnight fast of at least 10 hours. The study drug was swallowed together with 240 mL tap water (room temperature).

Timeline

• Start date: 2017-03-31
• Primary completion: 2017-05-24
• Completion: 2017-05-24
• First posted: 2021-08-05
• Last updated: 2021-08-05

Locations

1 site across 1 country: Netherlands