Finding studies
Finding studies
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Lead
Denovo Biopharma LLC
The primary objective of this study was to evaluate the safety and tolerability of escalating doses of LY2140023 in subjects with schizophrenia. The secondary objectives of this study were: * to characterize the pharmacokinetic (PK) parameters of LY2140023 and its active moiety - LY404039 in subjects with schizophrenia * to explore higher doses of LY2140023 in subjects with schizophrenia for use in further regulatory studies * to compare safety of LY2140023 to aripiprazole (ARP) * to access changes in pharmacodynamic (PD) measures (Clinical Global Impression-Severity Scale \[CGI-S\], Extrapyramidal Symptoms \[EPS\], and Brief Psychiatric Rating Scale \[BPRS\]) This was an inpatient, open-label, multiple-dose, multi-center study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated maximum therapeutic exposure under investigation.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
