Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3323795 · 1 trial · 1 indication
Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section.
| Arm | Type | Description |
|---|---|---|
| LY3323795 (Part A) | EXPERIMENTAL | Participants received escalating doses of 0.3 mg (milligrams), 1 mg, 3 mg, 10 mg, 30 mg and 100 mg of LY3323795 orally. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Participants received placebo identical to LY3323795 orally. |
| LY3323795 (Part B) | EXPERIMENTAL | Participants received 6 mg, 20 mg and 80 mg of LY3323795 orally. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Participants received placebo identical to LY3323795 orally. |
| LY3323795 (Part C) | EXPERIMENTAL | Part C was not initiated due to a Lilly internal strategy decision. |
| LY3323795 + Itraconazole (Part C) | EXPERIMENTAL | Part C was not initiated due to a Lilly internal strategy decision. |
| Name | Type | Description |
|---|---|---|
| LY3323795 | DRUG | Administered orally |
| Itraconazole | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria: * Healthy males or females of non-childbearing potential at time of screening * Have a body mass index (BMI) between 18.0 kilograms per square meter (kg/m²) and 32.0 kg/m², inclusive Exclusion Criteria: * Have participated, within the last 30 days, in a clinical trial involvin...
LY3323795 is an investigational small molecule developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy participants. The specific disease or condition it is intended to treat has not been disclosed.
LY3323795 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program for this investigational small molecule.
LY3323795 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
LY3323795 has been evaluated in one clinical trial, NCT02989389, titled A Study of LY3323795 in Healthy Participants. The Phase 1 trial was completed in the United States and enrolled 42 healthy volunteers.
The Phase 1 trial NCT02989389 was a randomized, double-blind, placebo-controlled study of LY3323795 in healthy participants. It enrolled 42 participants aged 20 years and older in the United States and has been completed.