drugset / Trial / NCT01354353

A Study of Safety and Tolerability in Subjects With Schizophrenia

NCT01354353

Phase 1 Completed 75 enrolled Denovo Biopharma LLC
Non-randomizedSingle-groupOpen-labelOther

Summary

This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated therapeutic exposure under clinical investigation. In the event of poor tolerability in Part A of this study Part B may be conducted to explore higher doses using titration. Participants in both Parts A and B will participate in a 9 day wash-out period of current medication (Study Days 1-9); participants coming into the study on aripiprazole will remain on their current therapy throughout.

Timeline

Start
2011-05
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject LY2140023 Unknown 160 mg Oral
Subject LY2140023 Unknown 240 mg Oral
Subject LY2140023 Unknown 320 mg Oral
Subject LY2140023 Unknown 400 mg Oral
Subject LY2140023 Unknown 480 mg Oral
Comparator Aripiprazole Other / unclassified Oral

Indications