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.