Safety assessments
Single ascending dosingSingle dose administration up to 600 mg Org 48775-0 in healthy male
volunteers did not result in any clinically significant changes in vital
signs, ECG-parameters and laboratory parameters. In particular, there
were no indications for any change in liver enzymes, signs of bone
marrow depression (anemia, thrombocytopenia or leucopenia), or
infections (leukocytemia). All adverse events were mild, transient and
completely reversible without medical intervention. Six adverse events
after dosing with Org 48775-0 were considered during the trial to be
possibly related to the study medication. The adverse events consisted
of dizziness and headache, one case of diarrhoea and a sterile,
catheter-related phlebitis was noted once. Only a few mild adverse
events of transient nature were reported in the food and gender
interaction study, considered to be unlikely related to study drug
administration. Also, none of the participants showed clinically
significant changes in vital signs, ECG-parameters or laboratory
parameters.