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| ID | Type | Description | Link |
|---|---|---|---|
| I7S-MC-HBEF | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to learn more about the safety and side effects of LY3154207 and fluconazole (anti-fungal medication), when taken together by healthy participants. The study will last from nine to 11 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Part A - LY3154207 Capsule | Experimental | LY3154207 capsule (reference) administered orally, once. |
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| Cohort 1 Part A - LY3154207 Tablet | Experimental | LY3154207 tablet (test) administered orally, once. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3154207 Capsule | Drug | Administered orally as capsule |
| |
| 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 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to 11 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Blood Pressure (BP) | BP measured by ambulatory blood pressure monitoring (ABPM) | Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole |
| Change from Baseline in Pulse Rate (PR) |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
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| ID | Term |
|---|---|
| C000707472 | LY3154207 |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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The capsule versus tablet formulation comparison will be open label.
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| 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. |
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| 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 Tablet |
| Drug |
Administered orally as tablet |
|
| Placebo | Drug | Administered orally as tablet |
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| Fluconazole Tablet | Drug | Administered orally as tablet |
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PR measured by ABPM
| Baseline, up to 48 hours post dose when LY3154207 is co-administered with fluconazole |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154207 | PK: Cmax of LY3154207 | Baseline up to 48 hours postdose |
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Time T, where T is the Last Sample with a Measurable Concentration (AUC[0-tlast]) of LY3154207 | PK: AUC(0-tlast) of LY3154207 | Baseline up to 48 hours postdose |
| PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3154207 | PK: AUC(0-inf) of LY3154207 | Baseline up to 48 hours postdose |