A Study Measuring Effect of Pomaglumetad Methionil (LY2140023) on Electrocardiographs in Participants With Schizophrenia



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:June 2012
End Date:December 2012
Contact:There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

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A Placebo- and Positive-Controlled Study of the Electrophysiological Effects on the QT Interval After a Supratherapeutic Dose of LY2140023 in Subjects With Schizophrenia


This study will determine if a single dose of pomaglumetad methionil affects the electrical
activity in the heart in people with schizophrenia. This study will also help determine how
a single high dose of pomaglumetad methionil is tolerated by participants.


Inclusion Criteria:

- Diagnosis of schizophrenia

- Female participants who are postmenopausal

- Not hospitalized for psychiatric illness for at least 12 weeks prior to Day 1 of the
study

- Willing and able to be hospitalized from Day 1 to the end of the study

- Can be washed out of their antipsychotic medication for the duration of the study

- Considered reliable, able to understand, and willing to perform all study procedures

- Understand the nature of the study and give written informed consent

- Clinical laboratory test results within normal reference range

- Venous access sufficient to allow blood sampling

- Clinically acceptable sitting blood pressure and heart rate

Exclusion Criteria:

- Currently enrolled in, have completed or have discontinued within the last 30 days
from a clinical trial involving an investigational drug

- Known allergies to pomaglumetad methionil or its active metabolite (LY404039),
moxifloxacin, related compounds or components

- Previously completed this study or prematurely discontinued from any study after
having received at least 1 dose of pomaglumetad methionil

- Received treatment with clozapine

- Received aripiprazole within 2 months prior to screening

- Taking either thioridazine or thiothixene

- Receiving treatment with depot antipsychotic medication within 12 weeks, prior to
screening

- Taking any medications other than those that are specifically permitted in the
protocol

- Asthma needing active beta 2 (B2) agonist within 14 days of the study

- Active suicidal ideation with some intent to act, without specific plan or with
specific plan and intent OR had suicidal behavior such as actual attempt, interrupted
attempt, aborted attempt, preparatory act or behavior within the past 3 months

- Substance dependence or substance abuse (except nicotine and caffeine) within the 6
months prior to admission

- Substance-induced psychosis within 7 days of admission (or at any time during the
dosing period)

- History of 1 or more seizures (with exceptions)

- Screening electroencephalogram (EEG) with paroxysmal (epileptiform) activity

- Have had electroconvulsive therapy (ECT) within 3 months of Day 1 of the study or who
are expected to have ECT at any time during the live phase of this study

- Parkinson's disease, dementia-related psychosis, or related disorders

- Untreated hyperthyroidism or hypothyroidism needing a thyroid hormone supplement who
have not been on a stable dose of medication for at least 2 months prior to screening

- History of leukopenia or agranulocytosis

- Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) or aspartate
aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) values greater
than 2 times the upper limit of normal (ULN) or total bilirubin values greater than
1.5 times the ULN of the performing laboratory at screening

- Abnormality in the 12-lead electrocardiogram (ECG) that increases the risks
associated with participating in the study

- Premature ventricular contraction (PVC) associated with symptoms and/or any complex
PVCs

- Heart rhythm disturbance by history or ECG at screening

- Personal or family history of long Q wave T wave (QT) syndrome

- Family history of sudden unexplained death or cardiac death in a family member under
60 years of age

- Unexplained syncope within the last year

- Acute, serious, or unstable medical conditions

- Prolactin level of greater than 200 nanograms per milliliter (ng/mL) (200 micrograms
per liter [ug/L], or 4228 milli-international units per liter [mIU/L]) at screening
(with the exception of participants treated with risperidone) at screening

- Medical history of Human Immunodeficiency Virus positive (HIV+) status

- Test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen
(HBsAg) with or without positive Hepatitis B core total antibody

- Smoke greater than or equal to 40 cigarettes per day

- Movement disorder that could interfere with conducting 12-lead ECGs
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Philadelphia, Pennsylvania 19107
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