This single-center, open-label, parallel group study will evaluate the effects of multiple doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours) from Day 1 to Day 17.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
34
Single oral dose
Multiple oral doses
Unnamed facility
Zuidlaren, Netherlands
Effect of multiple doses of ketoconazole on RO4602522 single dose pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22
Safety: Incidence of adverse events
Time frame: approximately 3 months
RO4602522 metabolites: Plasma/urine concentrations
Time frame: Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22
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