A study of safety and tolerability in subjects with schizophrenia (clinicaltrials.gov) - Aug 9, 2012 - P1, N=120; Recruiting -> Completed; Completion date: Jul 2012 -> Mar 2012
Trial completion • Trial completion date • Schizophrenia
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This study has been completed.
First Received on May 13, 2011. Last Updated on August 9, 2012 History of Changes Sponsor: Eli Lilly and Company
Information provided by (Responsible Party): Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01354353
Purpose
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. Subjects in both parts A and B will participate in a 9 day wash-out period of current medication (Study days 1-9); subjects coming into the study on aripiprazole will remain on their current therapy throughout.
Condition
Schizophrenia
Intervention
Drug: LY2140023
Drug: Aripiprazole
Phase
Phase 1
Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Safety and Tolerability of Multiple Ascending Doses of LY2140023 in Subjects With Schizophrenia
Resource links provided by NLM:
MedlinePlus related topics: Schizophrenia
Drug Information available for: Aripiprazole
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
Number of participants with clinically significant events (physical assessments and clinical lab tests) [ Time Frame: Baseline up to Day 21 for Part A; Baseline up to Day 29 for Part B ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
Part A: Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Pre dose and post dose on day 10 and day 16 ] [ Designated as safety issue: No ]
Part B: Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Pre-dose and post-dose on days 12, 15, 18, 21,and 24 ] [ Designated as safety issue: No ]
Part A: Pharmacokinetics, area under the concentration - time curve (AUC) [ Time Frame: Pre-dose and post-dose on Day 10 and Day 16 ] [ Designated as safety issue: No ]
Part B: Pharmacokinetics, area under the concentration - time curve (AUC) [ Time Frame: Pre-dose and post dose on days 12, 15, 18, 21,and 24 ] [ Designated as safety issue: No ]
Change from baseline in Clinical Global Impression- Severity Scale (CGI-S) [ Time Frame: Baseline through Day 17 for Part A, Baseline through Day 25 for Part B ] [ Designated as safety issue: Yes ]
Change from baseline in Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline through Day 17 for Part A, Baseline through Day 25 for Part B ] [ Designated as safety issue: Yes ]
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline through Day 17 for Part A, Baseline through Day 25 for Part B ] [ Designated as safety issue: Yes ]
Change from baseline through 21 days in Simpson-Angus Scale (SAS) [ Time Frame: Baseline through Day 17 for Part A, Baseline through Day 25 for Part B ] [ Designated as safety issue: Yes ]
Change from baseline through 21 days in Barnes Akathisia Scale (BAS) [ Time Frame: Baseline through Day 17 for Part A, Baseline through Day 25 for Part B ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 120
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
(IR5)
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