The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Dimebon following single ascending doses. A formal single ascending dose study of this nature has not been performed to date in the Dimebon development program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
12
Pfizer Investigational Site
Brussels, Belgium
Physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements, and adverse event monitoring.
Time frame: July 2009
Pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCinf, half-life, CL/F and Vz/F.
Time frame: July 2009
Pharmacodynamics: results of a Drug Effect Questionnaire
Time frame: once each arm
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Oral tablet; placebo, single dose