Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2140023 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 160 mg LY2140023 | EXPERIMENTAL | 80 mg LY2140023 administered orally, twice daily (BID) for up to 7 weeks. |
| 4 mg Risperidone | ACTIVE_COMPARATOR | 2 mg risperidone administered orally, BID for up to 7 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo administered orally, BID for up to 7 weeks. |
| 80 mg LY2140023 | EXPERIMENTAL | 40 mg LY2140023 administered orally, BID for up to 7 weeks. |
| 1 | EXPERIMENTAL | 160mg of LY2140023, taken orally as 80mg twice daily, for up to 4 weeks. |
| 2 | EXPERIMENTAL | 80mg of LY2140023, taken orally as 40mg twice daily, for up to 4 weeks. |
| 3 | EXPERIMENTAL | 40mg of LY2140023, taken orally as 20mg twice daily, for up to 4 weeks. |
| 4 | EXPERIMENTAL | 10mg of LY2140023, taken orally as 5mg twice daily, for up to 4 weeks. |
| 5 | PLACEBO_COMPARATOR | Placebo of LY2140023, taken orally twice daily, for up to 4 weeks. |
| 6 | ACTIVE_COMPARATOR | Placebo, taken orally every morning, followed by Olanzapine 15mg taken orally every evening for up to 4 weeks. |
| LY2140023 + ammonium chloride | EXPERIMENTAL | 1 g of ammonium chloride administered orally every 3 hours for 33 hours (totaling 12 doses) in combination with a single 80 mg dose of LY2140023 administered orally 17 hours after first dose of ammonium chloride (acidified urine). All participants will receive the three treatments in a randomized order. There will be a minimum of a 5 day wash out period between treatment periods. |
| LY2140023 + sodium bicarbonate | EXPERIMENTAL | 4 g of sodium bicarbonate administered orally every 4 hours for 32 hours (totaling 9 doses) in combination with a single 80 mg dose of LY2140023 administered orally 18 hours after first dose of sodium bicarbonate (alkalized urine). All participants will receive the three treatments in a randomized order. There will be a minimum of a 5 day wash out period between treatment periods. |
| LY2140023 | EXPERIMENTAL | A single 80 mg dose of LY2140023 administered orally (normal urine). All participants will receive the three treatments in a randomized order. There will be a minimum of a 5 day wash out period between treatment periods. |
| Name | Type | Description |
|---|---|---|
| Risperidone | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
| LY2140023 | DRUG | Administered orally. |
| Olanzapine | DRUG | 10mg, PO (by mouth) QPM (every evening) for the first 3 days, then 15mg PO QPM, for up to 4 weeks. |
| Ammonium chloride | DRUG | Administered orally |
| Sodium bicarbonate | DRUG | Administered orally |
Inclusion Criteria: * Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clini...
LY2140023 is an investigational small molecule being studied for the treatment of schizophrenia. It has also been evaluated in healthy subjects for research purposes. The drug is not approved and remains in clinical development.
LY2140023 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The company has sponsored clinical trials of the drug in schizophrenia patients and healthy volunteers.
LY2140023 is in Phase 1 clinical development. While two Phase 2 trials in schizophrenia have been completed, the most recent trial listed is a Phase 1 study in healthy subjects. The drug is investigational and not yet approved.
LY2140023 has been studied in three completed clinical trials. NCT00520923 and NCT01086748 were Phase 2 studies in schizophrenia patients, enrolling 654 and 880 participants respectively. NCT01440478 was a Phase 1 study in 30 healthy subjects examining urinary pH effects.
No alternative names for LY2140023 have been disclosed in the available information. The drug is identified solely by its code name LY2140023 in clinical trial registrations and related documentation.