This open-label, fixed sequence, two-period study will assess the effect of memantine on the pharmacokinetics, safety and tolerability of a single oral dose of RO5313534 and the effect of RO5313534 on safety and tolerability of steady-state memantine. Healthy volunteers will receive a single oral dose of RO5313534 on Day 1 of Treatment Period 1 (3 days). After a washout period of 5-21 days, oral memantine will be administered on Days 1-21 of Treatment Period 2 and a single dose of RO5313534 on Day 19. There will be a follow-up of 3-4 weeks after the last dose. Anticipated time on study for each volunteer is up to 14 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
16
single oral dose
multiple doses to steady state
Unnamed facility
Rennes, France
Effect of multiple-dose memantine on single-dose pharmacokinetics of RO5313534 and of RO5313534 on steady-state pharmacokinetics of memantine
Time frame: Days 16-21
Effect of multiple-dose memantine on safety and tolerability of single-dose RO5313534
Time frame: up to 14 weeks
Safety and tolerability of memantine alone and in combination with a single dose of RO5313534
Time frame: up to 7 weeks
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