This multiple-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, parallel group study will investigate the effect of RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized to one of 4 treatment arms; Arm A: low dose of RO4917838, Arm B: high dose of RO4917838, Arm C: placebo to RO4917838 and moxifloxacin on Day 1, Arm D: placebo to RO4917838 and moxifloxacin on Day 11. The anticipated time on study treatment is 11 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
169
Single oral dose on Day 1
Single oral dose on Day 11
Multiple daily low doses of RO4917838 for 10 days
Unnamed facility
Tempe, Arizona, United States
Unnamed facility
Strasbourg, France
Changes in QTcF interval at steady state
Time frame: Baseline and Day 10
Change of electrocardiogram
Time frame: Baseline and Day 10
Correlation of RO4917838 plasma concentration and the electrocardiogram
Time frame: Day 10
Change in the QTc interval, using moxifloxacin as an active control
Time frame: Days 1 and 11
Safety: incidence of adverse events
Time frame: 8 weeks
Pharmacokinetics: area under the concentration time curve of RO4917838
Time frame: Up to Day 19
Pharmacokinetics: Maximum plasma concentration of RO4917838
Time frame: Up to Day 19
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Multiple daily oral high doses of RO4917838 for 10 days
Oral daily doses of placebo to RO4917838 for 10 days