A Study Measuring Effect of LY2140023 (Pomaglumetad Methionil) on Electrocardiographs in Participants With Schizophrenia
Condition: Schizophrenic Disorders
MeSH terms: Schizophrenia
Intervention: LY2140023; Placebo; Moxifloxacin
Intervention description: Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study determined if a single dose of LY2140023 (pomaglumetad methionil) affects the
      electrical activity in the heart in participants with schizophrenia. This study also helped
      determine how a single high dose of LY2140023 is tolerated by participants.
    

Eligibility criteria:

        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 and have a Clinical Global Impression Severity Scale score of <4

          -  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 from a clinical trial
             involving an investigational drug within the last 30 days

          -  Known allergies to pomaglumetad methionil (LY2140023) 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 (LY2140023)

          -  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 QT wave 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