Multiple ascending dosing
The effect of repeated oral doses of Org 48775-0 was evaluated in a
randomized, double blind, placebo-controlled study in 30 healthy male
volunteers. Subjects were treated twice daily for 6 days with Org
48775-0. Three dose levels (30 mg, 70 mg and 150 mg Org 48775-0) were
selected (suspended in 2x100 mL of orange juice), based on the results
of the SAD study performed in healthy volunteers. Each cohort consisted
of 8 subjects that received active treatment and 2 that received
placebo. Dose escalation only took place after completion of the safety
evaluation of the previous dose level.