Multiple ascending dosing
Multiple dose administration in healthy male volunteers was not
associated with any clinically significant changes in vital signs,
ECG-recordings or laboratory parameters. A trend towards elevation was
observed in the liver enzyme alanine aminotransferase (ALAT) in several
subjects across all dose levels. The increases were completely resolved
at the follow up visit. No statistical differences in liver enzyme
levels could be observed between any Org 48775-0 treatment and placebo.
All adverse events reported in this study were considered mild in
severity. Forty-three adverse events after dosing with Org 48775-0 were
considered during the trial to be possibly related to the study
medication. The main reported adverse events were somnolence, dizziness,
headache and nasopharyngitis.