NCT01606436

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
10.6 years until next milestone

Results Posted

Study results publicly available

April 3, 2023

Completed
Last Updated

April 3, 2023

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

May 23, 2012

Results QC Date

August 30, 2021

Last Update Submit

March 30, 2023

Conditions

Schizophrenic Disorders

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline up to 12 Hours Postdose in QT Interval Corrected for Heart Rate (QTc)

    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. QT intervals from quadruplicate electrocardiogram (ECG) data were corrected for heart rate using Fridericia's formula: QTcF = QT/RR\^0.333, where RR is the interval between two R waves. Least squares (LS) mean changes from baseline in QTcF were calculated using a mixed-effects model with baseline QTcF, treatment, time, period, sequence, and the time-by-treatment interaction as fixed effects and participant and the participant-by-period interaction as random effects.

    Baseline, up to 12 hours postdose in each treatment period

Study Arms (3)

400 mg LY2140023

EXPERIMENTAL

400 milligrams (mg) LY2140023 (5 x 80 mg tablets) administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods.

Drug: LY2140023

Placebo

PLACEBO COMPARATOR

Placebo tablets (5) matching LY2140023 administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods.

Drug: Placebo

400 mg Moxifloxacin

OTHER

Positive control, unblinded 400 milligrams (mg) moxifloxacin (1 x 400 mg tablet) administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods.

Drug: Moxifloxacin

Interventions

LY2140023DRUG

Administered orally.

Also known as: pomaglumetad methionil
400 mg LY2140023
PlaceboDRUG

Administered orally.

Placebo
MoxifloxacinDRUG

Administered orally.

Also known as: Avelox
400 mg Moxifloxacin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

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, 92845, United States

Location

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, 92102, United States

Location

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, 33161, United States

Location

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, 66212, United States

Location

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, 20850, United States

Location

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, 63118, United States

Location

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, 19139, United States

Location

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, 78754, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

LY 2140023pomaglumetad methionilMoxifloxacin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 25, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

April 3, 2023

Results First Posted

April 3, 2023

Record last verified: 2012-09

Locations

US(8)