The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.
Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
single-dose
BIOTRIAL
Rennes, France
Adverse Events (AEs)
Safety was evaluated from the number of reported adverse events (AEs)
Time frame: 7 weeks
Cmax - BIA 9-1067
Cmax - maximum plasma concentration
Time frame: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose
Time to Cmax (Tmax)
Time frame: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose
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