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.