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 Nebicapone Small molecule 10 mg Oral
Subject Nebicapone Small molecule 30 mg Oral
Subject Nebicapone Small molecule 50 mg Oral
Subject Nebicapone Small molecule 100 mg Oral
Subject Nebicapone Small molecule 200 mg Oral
Subject Nebicapone Small molecule 400 mg Oral
Subject Nebicapone Small molecule 800 mg Oral

Indications