Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H8Y-MC-HBDJ | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
The decision to stop the trial was based on efficacy results in the overall schizophrenia patient population.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will evaluate the effect of food on absorption of LY2140023 in blood. This study involves a single dose of 80 mg LY2140023 taken as a tablet by mouth on 2 occasions, once on an empty stomach and once after eating breakfast. There is a minimum 3 day washout between doses. This study will last approximately 16 days not including screening. Screening is required within 30 days prior to the start of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2140023 fasting | Experimental | Single oral dose of 80 mg LY2140023 given in fasted state |
|
| LY2140023 + food | Experimental | Single oral dose of 80 mg LY2140023 given after standardized high-fat breakfast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2140023 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum concentration (Cmax) of LY2140023 and LY404039 | Up to 24 hours after administration of study drug | |
| Pharmacokinetics: Area under the concentration curve (AUC) of LY2140023 and LY404039 | Up to 24 hours after administration of study drug |
Not provided
Not provided
Inclusion Criteria:
Are healthy males or females, as determined by medical history and physical examination
Male participants agree to use a reliable method of birth control during the study and for 3 months following the last dose of LY2140023, and agree not to donate sperm for 3 months following the last dose of LY2140023
Female participants:
Exclusion Criteria:
Are currently enrolled in, have completed or discontinued within the last 90 days from, a clinical trial involving an investigational product other than the investigational product used in this study; or are 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 or LY404039, related compounds, activated charcoal, or any components of the formulation
Are persons who have previously withdrawn from this study or any other study investigating LY2140023 after receiving at least 1 dose of LY2140023
Show evidence or any history of significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression)
Have increased risk of seizures based on a history of:
Show evidence of active renal disease (for example, diabetic renal disease, polycystic kidney disease) or creatinine clearance less than 90 milliliters per minute (mL/min) as determined by the Cockroft Gault formula
Show evidence or any history of known substance dependence or abuse at any time (according to Diagnostic and Statistical Manual of Mental Disorders [DSM-IV] diagnosis), or regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Have a clinically significant abnormality in the neurological examination
Participants judged prior to randomization to be at suicidal risk by the investigator
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | Allschwil | CH-4123 |
Not provided
| ID | Term |
|---|---|
| C534551 | LY 2140023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Switzerland |