Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02989389 | A Study of LY3323795 in Healthy Participants | PHASE1 | COMPLETED | 42 | — | — | Dec 12, 2016 | Jul 21, 2017 | Apr 20, 2020 | 1 | United States |
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...