drugset / Trial / NCT04991181

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

NCT04991181

Phase 1 Completed 15 enrolled Bial - Portela C S.A.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-03-31
Primary completion
2017-05-24
Completion
2017-05-24

Drugs

EvaluationDrugModalityDoseRoute
Subject zamicastat Small molecule 400 mg Oral