This is a 2 part study to evaluate the safety and tolerability of supra-therapeutic doses of RO4602522 (Part A); and to investigate the effect of RO4602522 on the QTcF interval in healthy volunteers (Part B). Part A of the study will be a multiple-dose, randomized, double-blind, placebo-controlled study. Participants will be randomized to receive daily, oral doses of either RO4602522 or placebo for ten days. Part B of the study will be a multiple-dose, randomized, double-blind, double-dummy, placebo controlled, positive-control, parallel group study. Participants will be randomized to receive either multiple or single doses of RO4602522 or to receive single doses of moxifloxacin for 11 days. Pharmacokinetic parameters will be assessed for Parts A and B; and continuous ECG recordings will be made during Part B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
203
Daily oral doses
Daily oral doses
Single, oral dose
400 mg oral dose given on Day 1 or 11
Dose given orally on Days 1 and/or 11
Unnamed facility
Lenexa, Kansas, United States
Part A: Incidence of adverse events
Time frame: Up to 30 days
Part B: Continuous, 12-lead, Holter electrocardiogram (ECG) recordings
Time frame: Days -1 (screening) to 11
Parts A & B: Area under the concentration-time curve (AUC) of RO4602522
Time frame: Days 1 to 10
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