This randomized, Investigator/Subject-blind, adaptive single-ascending-dose, placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics (including the effect of food), and pharmacodynamics of RO5545965 following oral administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2 doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period of approximately 2 weeks between treatment periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
53
Single ascending dose
Single ascending dose
Single dose, in fed and fasted state
Unnamed facility
Zuidlaren, Netherlands
Safety: Incidence of adverse events
Time frame: up to approximately 10 weeks
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 48 hours post-dose
Pharmacokinetics: Maximum plasma concentration (Cmax)
Time frame: Pre-dose and up to 48 hours post-dose
Pharmacodynamics: Prolactin levels
Time frame: Pre-dose and up to 10 hours post-dose
Effect of food on the pharmacokinetics of single dose RO55459965: Area under the concentration-time curve (AUC)
Time frame: pre-dose and up to 48 hours post-dose
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