This is a single center, double-blind, placebo and positive-controlled, randomized, partial 6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of CEP-26401 (5, 25, and 125 μg) following single-dose administration to healthy male and female subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
40
Teva Investigational Site 38051
Leiden, Netherlands
Paired Associate Learning (PAL) Test
Time frame: Baseline to Hour 22
Rapid Visual Information Processing (RVIP) Test
Time frame: Baseline to Hour 22
Spatial Working Memory Test
Time frame: Baseline to Hour 22
Stop Signal Task (SST)
Time frame: Baseline to Hour 22
Adaptive tracking Test
Time frame: Baseline to Hour 22
Body sway Test
Time frame: Baseline to Hour 22
Leeds Sleep Evaluation Questionnaire (LSEQ)
Time frame: Baseline to Hour 22
Leiden Maze Test (LMT)
Time frame: Baseline to Hour 22
n-Back Working Memory Test
Time frame: Baseline to Hour 22
Polysomnography (PSG) Test
Time frame: Baseline to Hour 22
Saccadic Eye Movements
Time frame: Baseline to Hour 22
Single-Choice Reaction Time
Time frame: Baseline to Hour 22
Smooth Pursuit Eye Movements
Time frame: Baseline to Hour 22
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Placebos formulated to match each active drug
Visual Analog Scales (VAS)
Factors ranging from 'not at all' to 'extremely' are used to quantify subjective drug effects
Time frame: Baseline to Hour 22
area under the drug concentration-time curve (AUC0-t)
Time frame: Baseline to Hour 22
maximal observed plasma drug concentration (Cmax)
Time frame: Baseline to Hour 22
time to maximum observed plasma drug concentration (tmax)
Time frame: Baseline to Hour 22
Summary of participants with Adverse Events
Time frame: From signing of the consent form to Day 30