Healthy Volunteer Clinical Trial
Official title:
Randomized, Double-Blind, Double-Dummy, 5-Way Crossover Study to Evaluate the Abuse Potential of Cenobamate Relative to Alprazolam and Placebo When Administered Orally in Non-Dependent, Recreational Drug Users With Sedative Experience
This randomized, single-dose, placebo- and active-controlled, crossover study will evaluate
the abuse liability potential of cenobamate in recreational drug users with sedative drug use
experience.
In the Qualification phase, subjects will receive a single dose of either alprazolam or
placebo in a crossover design, with a wash-out period of at least 24 hours between
treatments. Subjects who are clearly able to distinguish the positive control from placebo
will be enrolled in the Treatment phase and will be randomized to single oral doses of
cenobamate (2 dose levels), alprazolam (2 dose levels), and placebo in a double-blind,
double-dummy, 5-way crossover design. Washout-periods between the 5 treatment periods in the
Treatment phase will be at least 16 days.
n/a
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