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LY3154207 · 7 trials · 4 indications
The CDR-CCB tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition). Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerized battery tests. For continuity of attention, the score range is -999 to 35. A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. Data presented are model-based bayesian posterior mean response rates with 95% credible interval.
Mean Connectivity and Mean Component Weight Between LY3154207 and Placebo in the Dorsal Attention Network (DAN), Frontoparietal Network (FPN), and Executive Control Network (ECN).
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo administered orally once a day (QD). |
| 10 milligram (mg) LY3154207 | EXPERIMENTAL | Participants received 10 mg LY3154207 administered orally QD. |
| 30 mg LY3154207 | EXPERIMENTAL | Participants received 30 mg LY3154207 administered orally QD. |
| 75 mg LY3154207 | EXPERIMENTAL | Participants received 75 mg LY3154207 administered orally QD. |
| LY3154207 | EXPERIMENTAL | LY3154207 administered orally in one of two study periods. |
| Cohort 1 Part A - LY3154207 Capsule | EXPERIMENTAL | LY3154207 capsule (reference) administered orally, once. |
| Cohort 1 Part A - LY3154207 Tablet | EXPERIMENTAL | LY3154207 tablet (test) administered orally, once. |
| Cohort 1 Part B LY3154207 (Dose 1) + Fluconazole | EXPERIMENTAL | LY3154207 (dose 1) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days. |
| Cohort 1 Part B - Placebo + Fluconazole | EXPERIMENTAL | Placebo administered alone, orally, once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days. |
| Cohort 2 - LY3154207 (Dose 2) + Fluconazole | EXPERIMENTAL | LY3154207 (dose 2) administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days. |
| Cohort 2 - Placebo + Fluconazole | EXPERIMENTAL | Placebo administered alone, orally once. Fluconazole administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days. |
| Cohort 3 - LY3154207 + Fluconazole | EXPERIMENTAL | LY3154207 (dose 2) administered alone, orally, on consecutive days. LY3154207 co-administered with fluconazole on consecutive days. |
| Cohort 3 - Placebo + Fluconazole | EXPERIMENTAL | Placebo administered alone, orally, on consecutive days. Placebo co-administered with fluconazole on consecutive days. |
| LY3154207 and [14C]-LY3154207 | EXPERIMENTAL | A single dose of LY3154207 and \[14C\]-LY3154207administered orally. |
| LY3154207 - Dose 1 | EXPERIMENTAL | LY3154207 administered orally in no more than one of the four periods. |
| LY3154207 - Dose 2 | EXPERIMENTAL | LY3154207 administered orally in no more than one of the four periods. |
| LY3154207 - Dose 3 | EXPERIMENTAL | LY3154207 administered orally in no more than one of the four periods. |
| Modafinil | ACTIVE_COMPARATOR | 200 mg modafinil administered orally in no more than one of the four periods. |
| LY3154207 (Part A) | EXPERIMENTAL | LY3154207 administered in ascending doses once orally in two of three study periods |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo matching LY3154207 administered once orally in one of three study periods. |
| LY3154207 (Part B) | EXPERIMENTAL | LY3154207 administered once orally. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Placebo matching LY3154207 administered once orally. |
| LY3154207 (Part C) | EXPERIMENTAL | LY3154207 administered once orally on Day 1 |
| LY3154207 + Itraconazole (Part C) | EXPERIMENTAL | Itraconazole administered orally (twice daily on Day 3 and then once daily to Day 12). LY3154207 co-administered once orally, on Day 9. Timing and duration of itraconazole dosing may be adjusted based on data from Part A. |
| Name | Type | Description |
|---|---|---|
| LY3154207 | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
| LY3154207 Capsule | DRUG | Administered orally as capsule |
| LY3154207 Tablet | DRUG | Administered orally as tablet |
| Fluconazole Tablet | DRUG | Administered orally as tablet |
| [14C]-LY3154207 | DRUG | Administered orally |
| Modafinil | DRUG | Modafinil administered orally. |
| Itraconazole | DRUG | Administered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution |
Inclusion Criteria: * Have dementia as defined by a decline in cognitive function, which in the opinion of the investigator has resulted in functional impairment. * Meet diagnostic criteria for PD per MDS criteria or DLB per 4th Consensus Report of the DLB Consortium. * Have a score on the MoCA of ...
LY3154207 is an investigational small molecule being studied for Lewy Body Dementia and Parkinson's Disease. It has also been evaluated in healthy participants in early-stage clinical trials. As of the available data, LY3154207 is in Phase 1 clinical development and is not approved by the FDA.
LY3154207 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical trials.
LY3154207 is in Phase 1 clinical development. All four clinical trials for this drug have been completed, and it remains an investigational agent. It has not received FDA approval.
LY3154207 has been studied in four completed Phase 1 trials. These include NCT02562768 in healthy participants and those with Parkinson's Disease, NCT03616795 in healthy male participants, NCT03942029 as a drug interaction study in healthy participants, and NCT04258826 evaluating its effects on the brain in healthy participants.
LY3154207 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported in the available clinical trial information.