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
This was designed as a single centre, phase I, double-blind, randomised, placebocontrolled study of three multiple rising doses in three sequential groups of 8 young male healthy volunteers (Part A) and a single group of healthy elderly volunteers (Part B). In Part B, 12 healthy elderly volunteers were to be enrolled. Ten were to be randomly allocated to BIA 3-202 and two to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
Guy's Drug Research Unit
London, United Kingdom
Maximum observed plasma concentration (Cmax) - D1
Time frame: Day 1
Time of maximum observed concentration (tmax) - D1
Time frame: Day 1
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D1
Time frame: Day 1
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D1
Time frame: Day 1
Maximum observed plasma concentration (Cmax) - D9
Time frame: Day 9
Time of maximum observed concentration (tmax) - D9
Time frame: Day 9
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D9
Time frame: Day 9
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D9
Time frame: Day 9
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