drugset / Trial / NCT02763787

Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202

NCT02763787 ↗

Phase 1 Completed 71 enrolled Bial - Portela C S.A.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to investigate the safety and tolerability of single oral rising doses of BIA 3-202 up to 800 mg (proposed doses 10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg) in groups of 9 healthy male adult subjects, to characterise the preliminary pharmacokinetics of single rising oral doses of BIA 3-202 in healthy male adult subjects, to investigate the effects of single doses of BIA 3-202 on COMT activity in human erythrocytes and to investigate the effect of food on the pharmacokinetics of a single dose of BIA 3-202.

Timeline

Start
2000-04
Primary completion
2000-06
Completion
2000-06

Drugs

EvaluationDrugModalityDoseRoute
Subject BIA 3-202 Unknown 10 mg Oral
Subject BIA 3-202 Unknown 30 mg Oral
Subject BIA 3-202 Unknown 50 mg Oral
Subject BIA 3-202 Unknown 100 mg Oral
Subject BIA 3-202 Unknown 200 mg Oral
Subject BIA 3-202 Unknown 400 mg Oral
Subject BIA 3-202 Unknown 800 mg Oral

Indications