Study population
A total of 57 male subjects were screened for participation however, 22
subjects were randomized and participated in the study.
Out of the total, 35 participants were not admitted to randomisation due
to the following reasons: 21 subjects did not meet one or more of the
selection criteria (16 at screening and 5 at admission), 7 subjects
decided to discontinue after the screening procedures, 3 subjects were
excluded due to an AE, 1 subject was lost to follow-up, 1 subject was
discontinued according to physician’s decision, and 2 subjects served as
back-up.
Regarding the 22 subjects admitted to randomisation, their age ranged
between 20 and 53 years (mean ± SD: 34 ± 7.5 years) and the majority
were Caucasian (81.8%). Weight varied between 57.8 kg and 93.4 kg
(76.4±10.1kg) and height was in the range of 167 cm and 190 cm (179±6.2
cm); mean body mass index (BMI) 23.8±2.8 kg/m2). All
these 22 subjects received at least one dose of IMP and had at least one
valid post-dose PD assessment (Safety population = 22 subjects; PD
population = 22 subjects). Of those, 21 subjects were included in the PK
set, completed both study periods without major protocol deviations, and
had at least one valid evaluable plasma zamicastat concentration (PP-PD
population = 21 subjects; PK population = 21 subjects). A total of 21
subjects completed the study, as one subject had a serious adverse event
and discontinued after first dosing, in period 1 of the study. This
subject was excluded from the PP-PD and PK populations since he was only
dosed with placebo. No concomitant medications administered to study
subjects were considered to have a relevant impact on PK, PD, and safety
analyses.