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| ID | Type | Description | Link |
|---|---|---|---|
| I7S-EW-HBEA | Other Identifier | Eli Lilly and Company |
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This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on the body. There will be 3 parts to this study.
Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for each participant. Each participant will receive two doses of LY3154207, if part A is completed.
Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each participant. Part B includes collecting fluid from the spinal column to measure levels of LY3154207.
Part C will include a single dose of LY3154207 given alone and then a second dose given along with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for each participant.
Participants may only enroll in 1 of the 3 parts of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Placebo (Part B) | Placebo Comparator | Placebo matching LY3154207 administered once orally. |
|
| LY3154207 (Part C) | Experimental | LY3154207 administered once orally on Day 1 |
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| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3154207 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Up to 48 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) Plasma Part A : Maximum Drug Concentration (Cmax) of LY3154207 | Predose through 48 hours after administration of study drug | |
| Pharmacokinetics (PK) Plasma Part A: Area Under the Concentration Curve (AUC) of LY3154207 | Predose through 48 hours after administration of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Salt Lake City | Utah | 84106 | United States |
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| ID | Term |
|---|---|
| C000707472 | LY3154207 |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Administered orally |
|
| Itraconazole | Drug | Administered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution |
|
| Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Area Under the Concentration Time Curve (AUC) of LY3154207 | Predose through 48 hours after administration of study drug |
| Pharmacokinetics (PK) Cerebrospinal Fluid (CSF) Part B: Maximum Drug Concentration (Cmax) of LY3154207 | Predose through 48 hours after administration of study drug |
| Pharmacokinetics (PK) Plasma Part C: Area Under the Concentration Time Curve (AUC) of LY3154207 when Co-administered with Itraconazole | Predose through 96 hours after administration of study drug |
| Pharmacokinetics (PK) Plasma Part C: Maximum Drug Concentration (Cmax) of LY3154207 when Co-administered with Itraconazole | Predose through 96 hours after administration of study drug |
| D010879 |
| Piperazines |