SchizophreniaPhase 1NCT01354353
A Study of Safety and Tolerability in Subjects With Schizophrenia
A Phase 1 study testing LY2140023 and Aripiprazole in people with Schizophrenia, run by Denovo Biopharma LLC at 2 sites in United States.
Trial summary
This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated therapeutic exposure under clinical investigation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- LY2140023 and Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to Mar 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
- Have a diagnosis of schizophrenic disorder
- Female participants who test negative for pregnancy at screening and agree to use a reliable method of birth control for the duration of the study and for at least 3 months after the last LY2140023 dose or are postmenopausal
- Not have been hospitalized for psychiatric illness for at least 12 weeks prior to Day 1 of washout period and have a Clinical Global Impression -Severity (CGI-S) scale score of <4
- Be willing and able as determined by the investigator to be hospitalized from the beginning of the washout period to the end of the study
- In the opinion of the investigator, the participant can be washed out of their Standard of Care (SOC) therapy (other than aripiprazole for the aripiprazole participants) for the duration of the study without detrimental effect to the participant's mental health (CGI-S <4 after completion of the washout period)
- Be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
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- Be able to understand the nature of the study and have given their own informed consent
- Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Have venous access sufficient to allow blood sampling
- Clinically acceptable sitting blood pressure and pulse rate, as determined by the investigator
- Participants on Aripiprazole prior to study entry must:
- On a stable dose of aripiprazole within the approved range in product labeling (less than or equal to 30 milligrams [mg]/day) for at least 60 days prior to Day 1 and with no anticipation of changes to dose, regimen (except as required for this study) or treatment within the next 1 month
Who cannot join
- Currently enrolled in, or discontinued within the 30 days prior to screening from, a clinical trial involving an investigational drug or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have known allergies to LY2140023, LY404039, aripiprazole, or related compounds
- Participants with moderate to severe renal impairment as defined by creatinine clearance (CrCl) <60 milliliters (mL)/minute (min)
- Have previously completed this study or have discontinued from any study investigating LY2140023 after having received at least 1 dose of LY2140023
- Participants for whom treatment with LY2140023 or aripiprazole as specified in this protocol, is relatively or absolutely clinically contraindicated
- Participants who have received treatment with clozapine
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- Participants who have a diagnosis of schizophrenia who are taking either thioridazine or thiothixene
- Participants receiving treatment with depot antipsychotic medication within 12 weeks, prior to screening
- Participants who are taking any of medications that are specifically excluded
- Participants who have answered 'yes' to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the Columbia suicide severity rating scale (C-SSRS), or answer "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the "Suicidal Behavior" portion of the C-SSRS; and the ideation or behavior occurred within the past 3 months
- Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (Text Revision) (DSM-IV-TR) diagnosis of substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to admission
- Diagnosis of substance-induced psychosis by DSM-IV-TR criteria within 7 days of admission (or at any time during the dosing period)
- Have a history of one or more seizures except for either of the following 2 situations: a single simple febrile seizure between ages 6 months and 5 years or a single seizure with an identifiable etiology, which has been completely resolved
- Have a screening electroencephalogram (EEG) with paroxysmal (epileptiform) activity, for example, one that demonstrates 3 or more focal sharp or spike waves, any sharp and slow wave complex, or any epileptiform discharge that is rhythmic, sustained, or generalized, or as locally defined
- Participants who have had electroconvulsive therapy (ECT) within 3 months of observation period or who are expected to have ECT at any time during the live phase of this study
- A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders
- Participant with 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
- Have leukopenia or history of leukopenia during the participant's lifetime
- Participants with alanine aminotransferase (ALT/SGPT) or aspartate aminotransferase (AST/SGOT) values >2 times the upper limit of normal (ULN) of the performing laboratory, or total bilirubin values >1.5 times the ULN of the performing laboratory at screening
- Participants with corrected QT interval (Bazett's); QTcB >450 milliseconds (msec) (male) or >470 msec (female) at admission
- Have acute, serious or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin A1c [HgbA1c] >8%), severe hypertriglyceridemia (fasting triglycerides greater than or equal to 500 milligrams/deciliter (mg/dL) or 5.65 micromoles/liter [umol/L]), hepatic insufficiency (specifically any degree of jaundice), recent cerebrovascular accidents, seizure disorders, serious acute systemic infection or immunology disease, unstable cardiovascular disorders (including ischemic heart disease), renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases
- Prolactin level of >200 nanograms/milliliter (ng/mL) (200 micrograms/liter [ug/L], or 4228 milli international units/liter [mIU/L]) at screening with the exception of participants treated with risperidone. Participants treated with risperidone are excluded if the prolactin level is >300 ng/mL (300 ug/L, or 6342 mIU/L) at screening
- Participants with known 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. Participants with positive Hepatitis B core antibody test and negative HBsAg may be included in the study if ALT/SGPT and AST/SGOT levels are less than 2 times the ULN and total bilirubin does not exceed the ULN of the central laboratory
Trial locations and contacts
2 sites in 1 country.
United States2 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.
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.
Glendale, California, 91206
About this study
Official title: Safety and Tolerability of Multiple Ascending Doses of LY2140023 in Subjects With Schizophrenia
This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated therapeutic exposure under clinical investigation. In the event of poor tolerability in Part A of this study Part B may be conducted to explore higher doses using titration. Participants in both Parts A and B will participate in a 9 day wash-out period of current medication (Study Days 1-9); participants coming into the study on aripiprazole will remain on their current therapy throughout.
Read the detailed description
The primary objective of this study was to evaluate the safety and tolerability of escalating doses of LY2140023 in subjects with schizophrenia.
The secondary objectives of this study were:
- to characterize the pharmacokinetic (PK) parameters of LY2140023 and its active moiety - LY404039 in subjects with schizophrenia
- to explore higher doses of LY2140023 in subjects with schizophrenia for use in further regulatory studies
- to compare safety of LY2140023 to aripiprazole (ARP)
- to access changes in pharmacodynamic (PD) measures (Clinical Global Impression-Severity Scale [CGI-S], Extrapyramidal Symptoms [EPS], and Brief Psychiatric Rating Scale [BPRS])
This was an inpatient, open-label, multiple-dose, multi-center study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated maximum therapeutic exposure under investigation.
- Conditions
- Schizophrenia
- Being tested
- LY2140023, Aripiprazole
- 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
AripiprazoleDrug
Also called Abilify
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole | Active comparator | Part A: Continue current prescribed dosing regimen -- Study Day 1 to discharge (Study Day 21). Part B: Continue current prescribed dosing regimen (≤ 30 milligrams [mg]/day ) -- Study Day 1 to discharge (Study Day 23, 25 or 28 based on adaptive design) Receives: Drug: Aripiprazole |
| Part A: 160 mg LY2140023 | Experimental | Administered orally, twice daily (BID) for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16) Receives: Drug: LY2140023 |
| Part A: 240 mg LY2140023 | Experimental | Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16) Receives: Drug: LY2140023 |
| Part A: 320 mg LY2140023 | Experimental | Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16) Receives: Drug: LY2140023 |
| Part A: 400 mg LY2140023 | Experimental | Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16) Receives: Drug: LY2140023 |
| Part A: 480 mg LY2140023 | Experimental | Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16) Receives: Drug: LY2140023 |
| Part B: LY2140023 | Experimental | If doses up to or equal to 400 mg BID are not tolerated, Part B of the study may be started. The dose of LY2140023 will be titrated in the same participant from highest dose that was tolerated in Part A, with the intention to reach a dose of 480 mg LY2140023. Receives: Drug: LY2140023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests)
Participants with at least 1 postdose (Day 10 through the end of study visit [Day 21]) treatment emergent adverse event (TEAE) were counted by dose cohort.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline up to Day 21 for Part A
Secondary outcomes (9)
Part A: Pharmacokinetics, Maximum Concentration (Cmax)
Measured: Pre-dose and post-dose on Day 10 and Day 16
Part B: Pharmacokinetics, Maximum Concentration (Cmax)
Part B (dose titration as defined in Part B of study) was not conducted because the objective of the study was met in part A.; therefore, no data are available for analysis of this secondary outcome
Measured: Pre-dose and post-dose on Days 12, 15, 18, 21, and 24
Part A: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC)
The Day 10 parameter is area under the concentration versus time curve from time zero to infinity (AUC[0-inf]) post-single dose of LY2140023. The Day 16 parameter is area under the concentration versus time curve in a dosing interval (AUC[0-tau]) post-repeated daily doses of LY2140023.
Measured: Pre-dose and post-dose on Day 10 and Day 16
Part B: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC)
Part B of this study was not conducted; therefore, no data are available for analysis.
Measured: Pre-dose and post-dose on Days 12, 15, 18, 21, and 24
Percentage of Participants With Increased Severity From Baseline to Day 17 in Clinical Global Impression- Severity Scale (CGI-S)
Clinical Global Impression- Severity Scale (CGI-S) measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The classification includes 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, and 7 = Among the most extremely ill patients. Increases or higher scores indicate increasing severity (=worse outcome) Only incidences of selected shifts of increasing severity (an increase in numbers on a scale) were reported for participants.
Part B of this study was not conducted; therefore, no data are available for analysis.
Measured: Baseline through Day 17 for Part A
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS)
Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a participant's general psychopathological symptoms. Item scores ranged from 0 (not assessed) to 7 (extremely severe). Total Scores ranged from 0 to 126. Increases or higher scores indicate a worsening of symptoms.
Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the 18-symptom construct) were reported for participants.
Part B of this study was not conducted; therefore, no data are available for analysis.
Measured: Baseline through Day 17 for Part A
Percentage of Participants With Worsening Severity From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)
The Abnormal Involuntary Movement Scale (AIMS) is a 14-item, clinician-rated scale to assess the severity of dyskinesias in patients taking neuroleptic drugs. Items 1 through 10 were rated using a 5-point (0-4) scale, items 11 through 14 were rated using a 2-point (no or yes) scale. The AIMS total score is the sum of items 1 through 10, and can range from 0-40. A higher score indicates a presence of more severe dyskinesias. Increases or higher scores indicate a worsening of symptoms.
The classification includes 0 = None, 1 = Minimal, may be extreme normal, 2 = Mild, 3 = Moderate, and 4 - Severe.
Only incidences of selected shifts of worsening severity (an increase in numbers on a scale within the 10-item construct) were reported for participants.
Part B of this study was not conducted; therefore, no data are available for analysis.
Measured: Baseline through Day 17 for Part A
Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS)
Simpson-Angus Scale (SAS) is used to measure Parkinsonian-type symptoms in participants exposed to antipsychotics. The scale consists of 10 items each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items. Increases or higher scores indicate a worsening of impairment.
Only incidences of selected shifts of increasing impairment (an increase in numbers on a scale within the 10-symptom construct) were reported for participants.
Part B of this study was not conducted; therefore, no data are available for analysis.
Measured: Baseline through Day 17 for Part A
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS)
Barnes Akathisia Rating Scale (BAS) evaluates observable, restless movements of drug-induced akathisia associated with use of antipsychotic medications, includes objective (1-item) and subjective component (2-items, awareness of movement and distress related to movement) plus Global Clinical Assessment for overall disorder. Components were rated on a 4-point scale for the objective (0 = normal and 3 = constantly restless) and subjective items ((0 = absence of inner restlessness and 3 = awareness of intense compulsion to move for one item; and 0 = no distress and 3 = severe for the other item) and scored on a 6-point scale for the Global Clinical Assessment (0 = absent and 5 = severe). Increases or higher scores indicate a worsening of symptoms.
Only incidences of selected shifts of worsening symptoms (an increase in numbers on a scale within the components) were reported for participants.
Part B of this study was not conducted; therefore, no data are available for analysis.
Measured: Baseline through Day 17 for Part A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionMar 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 SchizophreniaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT01354353
- Sponsor's protocol ID
- 13565
- Other IDs
- H8Y-MC-HBDB
- Status last verified
- Aug 2022
- First submitted
- 13 May 2011
- Last updated
- 14 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Multiple Ascending Doses of LY2140023 in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT01354353
- Acronym / sponsor ID
- 13565
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Denovo Biopharma LLCIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 May 2011 (estimated)
- Results
- Posted 14 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated therapeutic exposure under clinical investigation. In the event of poor tolerability in Part A of this study Part B may be conducted to explore higher doses using titration. Participants in both Parts A and B will participate in a 9 day wash-out period of current medication (Study Days 1-9); participants coming into the study on aripiprazole will remain on their current therapy throughout.
Detailed description
The primary objective of this study was to evaluate the safety and tolerability of escalating doses of LY2140023 in subjects with schizophrenia.
The secondary objectives of this study were:
- to characterize the pharmacokinetic (PK) parameters of LY2140023 and its active moiety - LY404039 in subjects with schizophrenia
- to explore higher doses of LY2140023 in subjects with schizophrenia for use in further regulatory studies
- to compare safety of LY2140023 to aripiprazole (ARP)
- to access changes in pharmacodynamic (PD) measures (Clinical Global Impression-Severity Scale [CGI-S], Extrapyramidal Symptoms [EPS], and Brief Psychiatric Rating Scale [BPRS])
This was an inpatient, open-label, multiple-dose, multi-center study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated maximum therapeutic exposure under investigation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole | Active comparator | Drug: AripiprazolePart A: Continue current prescribed dosing regimen -- Study Day 1 to discharge (Study Day 21). Part B: Continue current prescribed dosing regimen (≤ 30 milligrams [mg]/day ) -- Study Day 1 to discharge (Study Day 23, 25 or 28 based on adaptive design) |
| Part A: 160 mg LY2140023 | Experimental | Drug: LY2140023Administered orally, twice daily (BID) for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16) |
| Part A: 240 mg LY2140023 | Experimental | Drug: LY2140023Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16) |
| Part A: 320 mg LY2140023 | Experimental | Drug: LY2140023Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16) |
| Part A: 400 mg LY2140023 | Experimental | Drug: LY2140023Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16) |
| Part A: 480 mg LY2140023 | Experimental | Drug: LY2140023Administered orally BID for 6 days (Study Days 10-15) and as a single morning dose on the 7th day (Study Day 16) |
| Part B: LY2140023 | Experimental | Drug: LY2140023If doses up to or equal to 400 mg BID are not tolerated, Part B of the study may be started. The dose of LY2140023 will be titrated in the same participant from highest dose that was tolerated in Part A, with the intention to reach a dose of 480 mg LY2140023. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have a diagnosis of schizophrenic disorder
- Female participants who test negative for pregnancy at screening and agree to use a reliable method of birth control for the duration of the study and for at least 3 months after the last LY2140023 dose or are postmenopausal
- Not have been hospitalized for psychiatric illness for at least 12 weeks prior to Day 1 of washout period and have a Clinical Global Impression -Severity (CGI-S) scale score of <4
- Be willing and able as determined by the investigator to be hospitalized from the beginning of the washout period to the end of the study
- In the opinion of the investigator, the participant can be washed out of their Standard of Care (SOC) therapy (other than aripiprazole for the aripiprazole participants) for the duration of the study without detrimental effect to the participant's mental health (CGI-S <4 after completion of the washout period)
Key exclusion criteria (24 listed)
- Currently enrolled in, or discontinued within the 30 days prior to screening from, a clinical trial involving an investigational drug or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have known allergies to LY2140023, LY404039, aripiprazole, or related compounds
- Participants with moderate to severe renal impairment as defined by creatinine clearance (CrCl) <60 milliliters (mL)/minute (min)
- Have previously completed this study or have discontinued from any study investigating LY2140023 after having received at least 1 dose of LY2140023
- Participants for whom treatment with LY2140023 or aripiprazole as specified in this protocol, is relatively or absolutely clinically contraindicated
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 | Part A: 160 mg LY2140023, Part A: 240 mg LY2140023, Part A: 320 mg LY2140023, Part A: 400 mg LY2140023, Part A: 480 mg LY2140023, Part B: LY2140023 |
| AripiprazoleAlso: AbilifyAdministered orally | Drug | Aripiprazole |
Primary outcome
Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests)
Time frame: Baseline up to Day 21 for Part A
Participants with at least 1 postdose (Day 10 through the end of study visit [Day 21]) treatment emergent adverse event (TEAE) were counted by dose cohort. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
9 secondary outcomes
Part A: Pharmacokinetics, Maximum Concentration (Cmax)
Time frame: Pre-dose and post-dose on Day 10 and Day 16
Part B: Pharmacokinetics, Maximum Concentration (Cmax)
Time frame: Pre-dose and post-dose on Days 12, 15, 18, 21, and 24
Part A: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC)
Time frame: Pre-dose and post-dose on Day 10 and Day 16
Part B: Pharmacokinetics, Area Under the Concentration - Time Curve (AUC)
Time frame: Pre-dose and post-dose on Days 12, 15, 18, 21, and 24
Percentage of Participants With Increased Severity From Baseline to Day 17 in Clinical Global Impression- Severity Scale (CGI-S)
Time frame: Baseline through Day 17 for Part A
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Brief Psychiatric Rating Scale (BPRS)
Time frame: Baseline through Day 17 for Part A
Percentage of Participants With Worsening Severity From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)
Time frame: Baseline through Day 17 for Part A
Percentage of Participants With Increasing Impairment From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Simpson-Angus Scale (SAS)
Time frame: Baseline through Day 17 for Part A
Percentage of Participants With Worsening Symptoms From Baseline to Day 17 in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Scale (BAS)
Time frame: Baseline through Day 17 for Part A
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- 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
2 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 Aripiprazole in people with Schizophrenia, run by Denovo Biopharma LLC at 2 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 12 inclusion and 24 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 14 Sep 2021). 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?
Number of Participants With Clinically Significant Events (Physical Assessments and Clinical Lab Tests) (time frame: Baseline up to Day 21 for Part A). 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 14 Sep 2022.