This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
71
Single oral dose
Single oral dose
Unnamed facility
Christchurch, New Zealand
Safety: Incidence of adverse events
Time frame: 17 days
Pharmacokinetics: Area under the concentration-time curve
Time frame: Pre-dose and 1, 2, 4, 8, 12, 24, 72, 96, 144, 168 (+/-8), 216 (+/-24), 288 (1/-48) hours post-dose
Pharmacokinetics: Urine concentrations drug/metabolites
Time frame: Pre-dose and up to 72 hours post-dose
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