Schizophrenic DisordersPhase 1NCT01606436
A Study Measuring Effect of LY2140023 (Pomaglumetad Methionil) on Electrocardiographs in Participants With Schizophrenia
A Phase 1 study testing LY2140023 and Moxifloxacin in people with Schizophrenic Disorders, run by Denovo Biopharma LLC at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenic Disorders
- What is being tested?
- LY2140023 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
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
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
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
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
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
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
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
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
About this study
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
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.
Read the detailed description
The primary objective of this study was to determine that a single supratherapeutic dose of LY2140023 does not differ from placebo in the mean change from baseline in 12-lead electrocardiogram (ECG) QT interval measurements, such that the upper bound of the 2-sided 90% confidence interval (CI) for the greatest time-matched mean effect is <10 ms in subjects with schizophrenia. The secondary objective was to further evaluate the tolerability of a supratherapeutic single dose of LY2140023 monohydrate.
Male or female subjects diagnosed with schizophrenia and aged between 18 and 65 years, inclusive, who had not been hospitalized for psychiatric illness for at least 12 weeks prior to Day 1 of the lead-in period, and who had a Clinical Global Impression - Severity scale score of <4 were included in the study.
- Conditions
- Schizophrenic Disorders
- Being tested
- LY2140023, Placebo, Moxifloxacin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2140023Drug
Also called pomaglumetad methionil
Administered orally.
PlaceboDrug
Administered orally.
MoxifloxacinDrug
Also called Avelox
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, up to 12 hours postdose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Schizophrenic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denovo Biopharma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606436
- Sponsor's protocol ID
- 12676
- Other IDs
- H8Y-MC-HBCG
- Status last verified
- Sep 2012
- First submitted
- 23 May 2012
- Last updated
- 3 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01606436
- Acronym / sponsor ID
- 12676
- Conditions
- Schizophrenic Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Denovo Biopharma LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Posted 3 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study was to determine that a single supratherapeutic dose of LY2140023 does not differ from placebo in the mean change from baseline in 12-lead electrocardiogram (ECG) QT interval measurements, such that the upper bound of the 2-sided 90% confidence interval (CI) for the greatest time-matched mean effect is <10 ms in subjects with schizophrenia. The secondary objective was to further evaluate the tolerability of a supratherapeutic single dose of LY2140023 monohydrate.
Male or female subjects diagnosed with schizophrenia and aged between 18 and 65 years, inclusive, who had not been hospitalized for psychiatric illness for at least 12 weeks prior to Day 1 of the lead-in period, and who had a Clinical Global Impression - Severity scale score of <4 were included in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 400 mg LY2140023 | Experimental | Drug: LY2140023400 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets (5) matching LY2140023 administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods. |
| 400 mg Moxifloxacin | Other | Drug: MoxifloxacinPositive 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2140023Also: pomaglumetad methionilAdministered orally. | Drug | 400 mg LY2140023 |
| PlaceboAdministered orally. | Drug | Placebo |
| MoxifloxacinAlso: AveloxAdministered orally. | Drug | 400 mg Moxifloxacin |
Primary outcome
Change From Baseline up to 12 Hours Postdose in QT Interval Corrected for Heart Rate (QTc)
Time frame: Baseline, up to 12 hours postdose in each treatment period
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2140023 and Moxifloxacin in people with Schizophrenic Disorders, run by Denovo Biopharma LLC at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline up to 12 Hours Postdose in QT Interval Corrected for Heart Rate (QTc) (time frame: Baseline, up to 12 hours postdose in each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.