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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01606436
First received: May 23, 2012
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Schizophrenic Disorders
Drug: Pomaglumetad methionil
Drug: Matching placebo
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Placebo- and Positive-Controlled Study of the Electrophysiological Effects on the QT Interval After a Supratherapeutic Dose of LY2140023 in Subjects With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline up to 12 hours post dose in QT interval corrected for heart rate (QTc) [ Time Frame: Baseline, up to 12 hours post dose in each treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill
Placebo matching pomaglumetad methionil administered orally once during 1 of 3 crossover periods, separated by a 2 day washout period.
Drug: Matching placebo
Administered orally.
Experimental: 400 mg pomaglumetad methionil
400 mg pomaglumetad methionil administered orally once during 1 of 3 crossover periods, separated by a 2 day washout period.
Drug: Pomaglumetad methionil
Administered orally.
Other Name: LY2140023
400 mg Moxifloxacin
Positive control, unblinded moxifloxacin administered orally once during 1 of 3 crossover periods, separated by a 2 day washout period.
Drug: Moxifloxacin
Administered orally.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606436

Locations
United States, California
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Garden Grove, California, United States, 92845
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California, United States, 92102
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
North Miami, Florida, United States, 33161
United States, Kansas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Overland Park, Kansas, United States, 66212
United States, Maryland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rockville, Maryland, United States, 20850
United States, Missouri
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
St Louis, Missouri, United States, 63118
United States, Pennsylvania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Austin, Texas, United States, 78754
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01606436     History of Changes
Other Study ID Numbers: 12676, H8Y-MC-HBCG
Study First Received: May 23, 2012
Last Updated: September 28, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014