drugset / Trial / NCT04069130

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

NCT04069130

Phase 1 Completed 7 enrolled Bial - Portela C S.A.
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2019-01-22
Primary completion
2019-05-02
Completion
2019-05-02

Drugs

EvaluationDrugModalityDoseRoute
Subject zamicastat Small molecule 400 mg Oral