Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT analysis of ECGs), and pharmacokinetic parameters
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
125
Incidence of visual phenomena
Reported as adverse events
Time frame: Up to 12 days after last scheduled study day
Change in heart rate at rest
Time frame: Pre dose, up to 12 hours after drug administration
Investigator assessed tolerability on a 4 point scale
Time frame: Up to 12 days after last scheduled study day
Number of participants with abnormal findings in physical examination
Time frame: Up to 12 days after last scheduled study day
Number of participants with clinically significant changes in vital signs
Time frame: Up to 12 days after last scheduled study day
Number of participants with adverse events
Time frame: Up to 12 days after last scheduled study day
Characteristics of visual phenomena on a special questionnaire
Time frame: Up to 12 days after last scheduled study day
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to 12 days after last scheduled study day
Number of participants with abnormal findings in electrocardiogram (ECG)
Time frame: Up to 12 days after last scheduled study day
Area under the concentration-time curve of the analyte in plasma from zero time to 24 hours (AUC0-24)
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Time frame: Up to 24 hours after drug administration
Maximum plasma concentration following the first dose (Cmax)
Time frame: Up to 24 hours after drug administration
Time from first dose to the maximum plasma concentration (tmax)
Time frame: Up to 24 hours after drug administration
Terminal half-life (t1/2)
Time frame: Up to 24 hours after drug administration
Mean residence time of the analyte in the body after oral administration (MRTpo)
Time frame: Up to 24 hours after drug administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: Up to 24 hours after drug administration
Apparent volume of distribution during the terminal phase λz following extravascular administration (Vz/F)
Time frame: Up to 24 hours after drug administration