The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Placebo to Lu AF76432 oral solution
Lu AF76432 oral solution 2.5 mg/ml. Starting dose will be 3,5 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).
Parexel Early Phase Clinical Unit
Harrow, United Kingdom
Number of participants with Treatment-Emergent Adverse Events
Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)
Time frame: From dosing to 12 days
AUC0-t
Area under the plasma concentration-time curve from zero to time t
Time frame: From dosing to 72 hours post dose
Cmax
Maximum observed concentration
Time frame: From dosing to 72 hours post dose
AUC0-inf
Area under the plasma concentration-time curve from zero to infinity
Time frame: From dosing to 72 hours post dose
CL/F
Oral clearance
Time frame: From dosing to 72 hours post dose
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