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| ID | Type | Description | Link |
|---|---|---|---|
| H8Y-MC-HBDB | Other Identifier | Eli Lilly and Company |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2140023 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Day 21 for Part A |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics, Maximum Concentration (Cmax) | 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 |
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Inclusion Criteria:
Participants on Aripiprazole prior to study entry must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
This was a 2-part study. The lead-in period was from Days 1 to 9, the test dosing (treatment) period was from Days 10 to 16, and the follow-up period was from Days 17 to 21. Dose escalation in Part A was completed. Part B (dose titration) was optional and not initiated because the objective of the study was met in Part A.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge). |
| FG001 | 160 mg LY2140023 | 160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| FG002 | 240 mg LY2140023 | 240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| FG003 | 320 mg LY2140023 | 320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| FG004 | 400 mg LY2140023 | 400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| FG005 | 480 mg LY2140023 | 480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who were assigned to treatment and were either dosed or discontinued prior to dosing.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge). |
| BG001 | 160 mg LY2140023 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who were assigned to treatment and were either dosed or discontinued prior to dosing. | Posted | Number | participants | Baseline up to Day 21 for Part A |
|
Not provided
The analysis population included participants who received at least 1 dose of study drug (aripiprazole or LY2140023).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aripiprazole | Participants continued current prescribed dosing regimen of orally administered aripiprazole (≤ 30 milligrams [mg]/day) from Study Day 1 to Study Day 21 (discharge). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
No analyses were performed and results were not calculated for Part B of this study because the study was stopped prior to Part B being initiated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C534551 | LY 2140023 |
| C000626254 | pomaglumetad methionil |
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
Not provided
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| 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) |
|
| 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. |
|
|
| Aripiprazole | Drug | Administered orally |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline through Day 17 for Part A |
| United States |
| 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 | United States |
| Entry Criteria Not Met |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets.
(Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.)
| BG002 | 240 mg LY2140023 | 240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| BG003 | 320 mg LY2140023 | 320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| BG004 | 400 mg LY2140023 | 400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| BG005 | 480 mg LY2140023 | 480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 160 mg LY2140023 |
160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. (Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.) |
| OG002 | 240 mg LY2140023 | 240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| OG003 | 320 mg LY2140023 | 320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| OG004 | 400 mg LY2140023 | 400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
| OG005 | 480 mg LY2140023 | 480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. |
|
|
| Secondary | Part A: Pharmacokinetics, Maximum Concentration (Cmax) | Participants who received at least one dose of LY2140023 with evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Pre-dose and post-dose on Day 10 and Day 16 |
|
|
|
| Secondary | 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 | Zero participants were analyzed. | Posted | Pre-dose and post-dose on Days 12, 15, 18, 21, and 24 |
|
|
| Secondary | 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. | Participants who received at least one dose of LY2140023 with evaluable AUC data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliliter (ng*hr/mL) | Pre-dose and post-dose on Day 10 and Day 16 |
|
|
|
| Secondary | 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. | Zero participants were analyzed. | Posted | Pre-dose and post-dose on Days 12, 15, 18, 21, and 24 |
|
|
| Secondary | 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. | Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Clinical Global Impression- Severity Scale data. | Posted | Number | percentage of participants with shifts | Baseline through Day 17 for Part A |
|
|
|
| Secondary | 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. | Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Brief Psychiatric Rating Scale data. | Posted | Number | Percentage of participants with shifts | Baseline through Day 17 for Part A |
|
|
|
| Secondary | 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. | Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Abnormal Involuntary Movement Scale data. | Posted | Number | Percentage of participants with shifts | Baseline through Day 17 for Part A |
|
|
|
| Secondary | 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. | Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Simpson-Angus Scale data. | Posted | Number | Percentage of participants with shifts | Baseline through Day 17 for Part A |
|
|
|
| Secondary | 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. | Participants who received at least one dose of LY2140023 with evaluable baseline and Day 17 Barnes Akathisia Scale data. | Posted | Number | Percentage of participants with shifts | Baseline through Day 17 for Part A |
|
|
|
| 1 |
| 16 |
| 8 |
| 16 |
| EG001 | 160 mg LY2140023 | 160 mg LY2140023 administered orally twice daily (BID) to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. (Included in this arm are six participants who, rather than the assigned 160 mg BID LY2140023 dosage, erroneously received oral 80 mg LY2140023 BID on Study Days 10-15 and as a single, oral morning dose on Study Day 16.) | 0 | 11 | 7 | 11 |
| EG002 | 240 mg LY2140023 | 240 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. | 1 | 10 | 9 | 10 |
| EG003 | 320 mg LY2140023 | 320 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. | 0 | 11 | 11 | 11 |
| EG004 | 400 mg LY2140023 | 400 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. | 0 | 11 | 11 | 11 |
| EG005 | 480 mg LY2140023 | 480 mg LY2140023 administered orally BID to participants on Study Days 10-15 and as a single, oral morning dose on Study Day 16. Administration of study drug included receiving the appropriate number of 80 mg LY2140023 tablets. | 0 | 11 | 11 | 11 |
| Agitation | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Energy increased | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Feeling of body temperature change | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Electrocardiogram qt prolonged | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Electroencephalogram abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Drooling | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Poor quality sleep | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Anticipatory anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Enuresis | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
| Day 16 (multiple doses) |
|
|
|
| Day 16 (multiple doses) (n=4, 9, 7, 11, 4) |
|
|
| Shift from Mild to Moderate |
|
| Mild to moderately severe - Anxiety |
|
| Very mild to moderate - Unusual thought content |
|
| Very mild to moderate - Excitement |
|
| Very mild to moderate - Conceptual disorganization |
|
| Normal to Minimal - Muscles of facial expression |
|
| Normal to Slight - Head dropping |
|
| Normal to Slight - Tremor |
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| Normal to Slight - Salivation |
|
| Normal to Slight - Glabella tap |
|
| Subjective - Awareness - Absence to non-specific |
|
| Subjective - Distress - No distress to mild |
|
| Global - Absent to questionable |
|