This open-label, fixed-sequence, two-period study will assess the effect of multiple dose valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
18
Unnamed facility
Rueil-Malmaison, France
Effect of valproate multiple-dose administration on pharmacokinetics of RO4917838 at steady-state: Area under the concentration-time curve (AUC)
Time frame: Period 2, day 10 and day 15
Effect of RO4917838 multiple-dose administration on the pharmacokinetics of valproate at steady state: Area under the concentration-time curve (AUC)
Time frame: Period 1, day 5 and Period 2, Day 15
Safety: Incidence of adverse events
Time frame: 16 days
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