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| ID | Type | Description | Link |
|---|---|---|---|
| H8Y-MC-HBCG | Other Identifier | Eli Lilly and Company |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2140023 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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 |
All participants had to go through a lead in 7-day antipsychotic medication washout.
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2140023 Then Placebo Then Moxifloxacin | Single 400-mg oral dose of LY2140023 - Day 8 Washout - Days 9-10 Single oral dose of LY2140023-matched placebo - Day 11 Washout - Day 12-13 Single 400-mg oral dose of moxifloxacin (Avelox) - Day 14 Washout - Day 15-16 |
| FG001 | Placebo Then Moxifloxacin Then LY2140023 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Administered orally. |
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| Moxifloxacin | Drug | Administered orally. |
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| 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. | San Diego | California | 92102 | 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. | North Miami | Florida | 33161 | 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. | Overland Park | Kansas | 66212 | 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. | Rockville | Maryland | 20850 | 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. | St Louis | Missouri | 63118 | 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. | Philadelphia | Pennsylvania | 19139 | 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. | Austin | Texas | 78754 | United States |
Single oral dose of LY2140023-matched placebo- Day 8 Washout - Days 9-10 Single 400-mg oral dose of moxifloxacin (Avelox)- Day 11 Washout - Day 12-13 Single 400-mg oral dose of LY2140023 - Day 14 Washout - Day 15-16 |
| FG002 | Moxifloxacin Then LY2140023 Then Placebo | Single 400-mg oral dose of moxifloxacin (Avelox)- Day 8 Washout - Day 9-10 Single 400-mg oral dose of LY2140023 - Day 11 Washout - Day 12-13 Single oral dose of LY2140023-matched placebo- Day 14 Washout - Days 15-16 |
| FG003 | Placebo Then LY2140023 Then Moxifloxacin | Single 400-mg oral dose of placebo- Day 8 Washout - Day 9-10 Single 400-mg oral dose of LY2140023- Day 11 Washout - Day 12-13 Single oral dose of moxifloxacin (Avelox) - Day 14 Washout - Days 15-16 |
| FG004 | Moxifloxacin the Placebo Then LY2140023 | Single oral dose of moxifloxacin (Avelox) - Day 8 Washout - Day 9-10 Single 400-mg oral dose of placebo- Day 11 Washout - Day 12-13 Single 400-mg oral dose of LY2140023- Day 14 Washout - Days 15-16 |
| FG005 | LY2140023the Moxifloxacin the Placebo | Single 400-mg oral dose of LY2140023- Day 8 Washout - Day 9-10 Single oral dose of moxifloxacin (Avelox) - Day 11 Washout - Day 12-13 Single 400-mg oral dose of placebo- Day 14 Washout - Days 15-16 |
| Received First Intervention |
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| Received Second Intervention |
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| Received Third Intervention |
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| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | After completing a 7-day antipsychotic medication washout period (Days 1 to 7), participants still meeting eligibility criteria were randomized to receive single doses of LY2140023 (Treatment A), matching placebo (Treatment B), and moxifloxacin (Treatment C) in 1 of 6 treatment sequences (ABC, BCA, CAB, BAC, CBA, or ACB). Study drug was administered on Days 8, 11, and 14 of the study. LY2140023 (pomaglumetad methionil): 400 milligrams (mg) (5 x 80 mg tablets), administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods. placebo: 5 tablets, administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods. moxifloxacin: 400 mg tablet, administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kilograms |
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| 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 | 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. | All participants who received at least 1 dose of LY2140023, moxifloxacin, or placebo and had evaluable QTcF data | Posted | Least Squares Mean | 90% Confidence Interval | milliseconds | Baseline, up to 12 hours postdose in each treatment period |
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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 | 400 mg LY2140023 | LY2140023 (pomaglumetad methionil): 400 milligrams (mg) (5 x 80 mg tablets), administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods. | 1 | 81 | 52 | 81 | ||
| EG001 | 400 mg Moxifloxican | moxifloxacin: 400 mg tablet, administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods. | 0 | 82 | 13 | 82 | ||
| EG002 | Placebo | placebo: 5 tablets, administered orally as a single dose during 1 of 3 treatment periods separated by 2-day washout periods. | 0 | 80 | 19 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Gingivitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Lip oedema | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Retching | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Tongue disorder | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Rash pustular | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Nystagmus | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| 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 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| 2.0 hours |
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| 3.0 hours |
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| 4.0 hours |
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| 5.0 hours |
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| 6.0 hours |
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| 8.0 hours |
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| 12.0 hours |
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| LS Mean Difference |
| 2.89 |
| 2-Sided |
| 90 |
| 1.05 |
| 4.73 |
| Superiority or Other (legacy) |
| Comparison at 3.0 hours postdose. | LS Mean Difference | 2.11 | 2-Sided | 90 | 0.28 | 3.95 | Superiority or Other (legacy) |
| Comparison at 4.0 hours postdose. | LS Mean Difference | 1.48 | 2-Sided | 90 | -0.36 | 3.32 | Superiority or Other (legacy) |
| Comparison at 5.0 hours postdose. | LS Mean Difference | 1.48 | 2-Sided | 90 | -0.36 | 3.32 | Superiority or Other (legacy) |
| Comparison at 6.0 hours postdose. | LS Mean Difference | 3.48 | 2-Sided | 90 | 1.64 | 5.32 | Superiority or Other (legacy) |
| Comparison at 8.0 hours postdose. | LS Mean Difference | 2.12 | 2-Sided | 90 | 0.27 | 3.97 | Superiority or Other (legacy) |
| Comparison at 12.0 hours postdose. | LS Mean Difference | 1.67 | 2-Sided | 90 | -0.17 | 3.51 | Superiority or Other (legacy) |
| Comparison at 0.5 hours postdose. | LS Mean Difference | 1.01 | 2-Sided | 90 | -1.57 | 3.59 | Superiority or Other (legacy) |
| Comparison at 2.0 hours postdose. | LS Mean Difference | 4.99 | 2-Sided | 90 | 2.40 | 7.57 | Superiority or Other (legacy) |
| Comparison at 3.0 hours postdose. | LS Mean Difference | 6.28 | 2-Sided | 90 | 3.71 | 8.86 | Superiority or Other (legacy) |
| Comparison at 4.0 hours postdose. | LS Mean Difference | 6.35 | 2-Sided | 90 | 3.78 | 8.93 | Superiority or Other (legacy) |
| Comparison at 12.0 hours postdose. | LS Mean Difference | 4.71 | 2-Sided | 90 | 2.11 | 7.31 | Superiority or Other (legacy) |