The purpose of the trial is to determine if Lu AH69593 is safe and well tolerated. The trial will also look at how the body processes Lu AH69593 with and without food.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
Lu AH69593 will be administered per schedule specified in the arm description.
Placebo will be administered per schedule specified in the arm description.
Terveystalo Helsinki, Sleep Clinic
Helsinki, Finland
RECRUITINGCRST, Clinical Research Services Turku
Turku, Finland
RECRUITINGNumber of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 90
Bond Lader Visual Analogue Scale (VAS) dimension scores (Alertness, Contentedness, and Calmness)
Time frame: Baseline up to Day 84
Psychomotor Vigilance Task (PVT) Parameter - Change From Baseline in Reaction Time to Stimuli
Time frame: Baseline, up to Day 11
PVT Parameter - Change From Baseline in Number of Errors of Omission
Time frame: Baseline, up to Day 11
PVT Parameter - Change From Baseline in Number of Errors of Commission (Response Without Stimulus)
Time frame: Baseline, up to Day 11
Number of Participants With Suicidal Ideation and Behaviour Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline up to Day 90
Area Under the Curve (AUC) From Zero to Time of Last Quantifiable Concentration (AUC0-t) of Lu AH69593
Time frame: Up to 84 days
Maximum Observed Plasma Concentration (Cmax) of Lu AH69593
Time frame: Up to 84 days
Time to Reach Cmax (Tmax) of Lu AH69593
Time frame: Up to 84 days
AUC From Time Zero to Infinity (AUC0-inf)
Time frame: Up to 6 days
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