CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 75 enrolled
Drug / intervention
LY2140023 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01354353
NCT01354353Phase 1Completed

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

Denovo Biopharma LLC·interventional·Posted May 16, 2011·Updated Sep 14, 2022

In Brief

A Phase 1 clinical trial evaluating LY2140023 and Aripiprazole for Schizophrenia. Completed, enrolled 75 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 16, 2011
Enrollment StartMay 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.1 years ago

Interventions

LY2140023drug

Administered orally

Aripiprazoledrug

Administered orally