NCT01354353

A Study of Safety and Tolerability in Subjects With Schizophrenia

Safety and Tolerability of Multiple Ascending Doses of LY2140023 in Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Denovo Biopharma LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	LY2140023	Administered orally
DRUG	Aripiprazole	Administered orally

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-05-16
• Last updated: 2022-09-14
• Results posted: 2021-09-14

Locations

2 sites across 1 country: United States