Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J4U-MC-KTAA | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this first-in-human study to investigate the safety of LY3839840 in single and multiple doses, and how it's processed in the body when given in different amounts.
The study will be conducted in five parts (A, B, C, D, and E) and each enrolled participant will receive a single dose (Parts A and C) or multiple dose (Parts B, C and D) of either LY3839840 or placebo. Part E will study midazolam alone and with LY3839840. The study will last up to approximately 7 weeks for parts A, C (single dose cohort), 8 weeks for parts B, D and C (multiple dose cohort), and up to 3 weeks for Part E.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3839840 (Part A) | Experimental | Single ascending dose of LY3839840 administered orally. |
|
| LY3839840 (Part B) Cohort 1-3 | Experimental | Multiple ascending dose of LY3839840 administered orally. |
|
| LY3839840 (Part B) Cohort 4 | Experimental | Multiple ascending dose of LY3839840 administered orally. |
|
| LY3839840 (Part B) Optional Cohort 5 | Experimental | Multiple ascending dose of LY3839840 administered orally pending data from Cohort 4 |
|
| LY3839840 (Part C) | Experimental | Single and multiple dose of LY3839840 administered orally in Chinese participants. |
|
| LY3839840 (Part D) | Experimental | Multiple ascending dose of LY3839840 administered orally in Japanese participants. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3839840 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration | A summary of AEs, TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the reported adverse events module | Baseline up to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3839840 | PK:Cmax of LY3839840 | Predose on day 1 up to 14 days post dose |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3839840 |
Not provided
Inclusion Criteria:
Healthy men and women. Women may only be included if they are of nonchildbearing potential
For Part C:
• Part C of the study includes Chinese participants only. To qualify, the participants must be considered as native Chinese, defined as all the participant's biological grandparents being of Chinese origin
For Part D:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel ACT | Anaheim | California | 92801 | United States | ||
| Fortrea Clinical Research Unit |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Part E is non-randomized and open-label
|
| Placebo (Parts A-D) | Placebo Comparator | Placebo administered orally. |
|
| Midazolam (Part E) | Experimental | Midazolam substrate alone or with LY3839840 administered orally |
|
| Placebo | Drug | Administered orally. |
|
| Midazolam | Drug | Administered orally |
|
PK: AUC of LY3839840
| Predose on day 1 up to 14 days post dose |
| PK: AUC of Midazolam | PK: AUC of Midazolam | Predose on day 1 up to 19 days post-dose |
| PK: Cmax of Midazolam | PK: Cmax of Midazolam | Predose on day 1 up to 19 days post-dose |
| Madison |
| Wisconsin |
| 53704 |
| United States |
| D006571 | Heterocyclic Compounds |