Approval Probability
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LY2979165 · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 10 mg LY2140023 + ketamine | EXPERIMENTAL | Single oral dose of 10 mg LY2140023 followed by intravenous (IV) ketamine during one of the crossover periods |
| 20 mg LY2979165 + ketamine | EXPERIMENTAL | Single oral dose of 20 mg LY2979165 followed by IV ketamine during one of the crossover periods |
| 40 mg LY2140023 + ketamine | EXPERIMENTAL | Single oral dose of 40 mg LY2140023 followed by IV ketamine during one of the crossover periods |
| 60 mg LY2979165 + ketamine | EXPERIMENTAL | Single oral dose of 60 mg LY2979165 followed by IV ketamine during one of the crossover periods |
| 160 mg LY2140023 + ketamine | EXPERIMENTAL | Single oral dose of 160 mg of LY2140023 followed by IV ketamine during one of the crossover periods |
| Placebo capsules + ketamine | PLACEBO_COMPARATOR | Single oral dose of placebo capsules followed by IV ketamine during one of the crossover periods |
| Placebo tablets + ketamine | PLACEBO_COMPARATOR | Single oral dose of placebo tablets followed by IV ketamine during one of the crossover periods |
| LY2979165 Part A, Cohort 1 | EXPERIMENTAL | 20 mg LY2979165 administered orally, daily for 14 days |
| LY2979165 Part A, Cohort 2 | EXPERIMENTAL | 60 mg LY2979165 administered orally, daily for 14 days |
| LY2979165 Part A, Cohort 3 | EXPERIMENTAL | 100 mg LY2979165 administered, orally daily for 14 days |
| LY2979165 Part A, Cohort 4 | EXPERIMENTAL | 150 mg LY2979165 administered orally, daily for 14 days |
| LY2979165 Part B, Cohort 5 | EXPERIMENTAL | Dose to be determined by safety review of doses administered in Part A, administered, orally daily for 14 days |
| Placebo | PLACEBO_COMPARATOR | Administered orally, daily for 14 days in a ratio of 3:1 in each Cohort of Part A |
| LY2979165 Part A, Cohort 6 | EXPERIMENTAL | 250 mg LY2979165 administered orally, daily for 14 days |
| LY2979165 Part A, Cohort 7 | EXPERIMENTAL | 400 mg LY2979165 administered orally, daily for 14 days |
| LY2979165 (Part A) | EXPERIMENTAL | single oral doses at dose levels ranging from 20 to 1000 mg |
| Placebo (Part A) | PLACEBO_COMPARATOR | single oral dose |
| LY2979165 - low dose (Part B) | EXPERIMENTAL | single oral low dose of LY297165 (dose to be determined by Part A) |
| LY2979165 - high dose (Part B) | EXPERIMENTAL | single oral high dose of LY2979165 (dose determined from Part A) |
| Placebo - Part B | PLACEBO_COMPARATOR | single oral dose |
| Name | Type | Description |
|---|---|---|
| LY2979165 | DRUG | Capsules administered orally |
| LY2140023 | DRUG | Tablets administered orally |
| Placebo | OTHER | Administered orally |
| Ketamine | OTHER | Administered intravenously (IV) |
Inclusion Criteria: * are overtly healthy, right-handed, Caucasian (non-Hispanic White by self report) males, as determined by medical history and physical examination * agree to use an effective method of birth control during the study and for a period of 3 months after the final dose of study dru...
LY2979165 is an investigational small molecule being studied for use in bipolar disorder and in healthy volunteers. It is in Phase 1 clinical development, meaning it is still being tested in early-stage trials to evaluate its safety and tolerability in humans. LY2979165 is not approved by the FDA.
LY2979165 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting early-stage clinical trials to investigate the drug's safety and tolerability in healthy volunteers and in people with bipolar disorder.
LY2979165 is in Phase 1 clinical development. All three of its clinical trials are Phase 1 studies that have been completed. The drug is investigational and has not been approved by regulatory authorities. It is being studied primarily in healthy volunteers to assess safety and tolerability.
LY2979165 has been studied in three completed Phase 1 clinical trials: NCT01248052, a first human dose study in healthy volunteers in Singapore; NCT01383967, a study in healthy subjects in Singapore; and NCT01524237, a study of LY2979165 and LY2140023 in healthy male volunteers in the United Kingdom. All trials are completed.
No, LY2979165 and LY2140023 are different investigational drugs. They were studied together in a single clinical trial, NCT01524237, which evaluated both compounds in healthy volunteers. LY2979165 is being developed by Eli Lilly and Company for potential use in bipolar disorder.