This single center, randomized, single dose, open-label, four period cross-over study will evaluate the relative bioavailability of RO4917838 and the effect of food following oral administration in healthy volunteers. Subjects will receive in randomized order single oral doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838 hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days between treatments. Anticipated time on study will be up to 23 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
16
Unnamed facility
Rueil-Malmaison, France
Effect of high fat and high caloric food on the relative bioavailability of single dose RO4917838 film coated tablets (FCT): Area under the concentration-time curve (AUC)
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
Relative bioavailability of single dose RO4917838 hard gelatin capsules as compared to FCT: Area under the concentration-time curve
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
Relative bioavailability of single dose RO4917838 oral suspension as compared to FCT
Time frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
Safety: Incidence of adverse events
Time frame: approximately 2 months
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