drugset / Trial / NCT02763800

Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202

NCT02763800

Phase 1 Completed 33 enrolled Bial - Portela C S.A.
RandomizedParallel-groupDouble-blindTreatment

Summary

The objectives as stated in the study protocol were as follows: * To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202 (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male volunteers). Part A * To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA 3-202 in healthy young males. Part A * To investigate the safety and tolerability of a single multiple dose regimen (dose to be determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B * To characterise the steady state pharmacokinetic and pharmacodynamic profile of a single multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in healthy elderly volunteers. Part B

Timeline

Start
2000-09
Primary completion
2001-01
Completion
2001-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Nebicapone Small molecule 50 mg Oral
Subject Nebicapone Small molecule 100 mg Oral
Subject Nebicapone Small molecule 200 mg Oral

Indications