The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to patients with schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
PAREXEL Phase I Unit
Glendale, California, United States
Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG)
Time frame: Screening to day 78 (up to 8 weeks after last dose)
Change from baseline in AIMS, BARS and SAS Total score
Abnormal movement rating scale
Time frame: Baseline to day 21
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Sceening to day 78 (up to 8 weeks after last dose)
Day 21 area under the Lu AF35700 and Lu AF36152 plasma concentration-time curve from 0-24 hours post dose (AUC0-tau) in a daily dosing regime
Time frame: Day 21 in the dosing period
Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152
Time frame: Day 1 and 21 in the dosing period
Half-lives (t½) of Lu AF35700 and Lu AF36152
Time frame: Day 1 and 21 in the dosing period
Day 14-21 area under the Lu AF35700 and LuAF36152 plasma-concentration-time curve from 0-168 hours post-dose (AUCtau) in a weekly dosing regimen
Time frame: Day 14-21 in the dosing period
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