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| ID | Type | Description | Link |
|---|---|---|---|
| J6P-MC-NFAC | Other Identifier | Eli Lilly and Company |
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The purpose of the study is to see how itraconazole affects LY4395089 in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
There will be fifteen inpatient stays at the clinical research unit (CRU). The study will last about 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4395089 | Experimental | LY4395089 administered orally |
|
| Itraconazole | Experimental | Itraconazole administered orally |
|
| LY4395089 + Itraconazole | Experimental | LY4395089 and Itraconazole administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4395089 | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from 0 to infinity (AUC[0-∞]) of LY4395089 | Baseline up to Day 15 | |
| PK: Maximum Concentration (Cmax) of LY4395089 | Baseline up to Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
Have a significant history or presence of the following conditions:
Have any medical conditions, medical history, or are taking any medications that are contraindicated in the itraconazole prescribing information, such as prior history of hypersensitivity to itraconazole or other -azoles
Have any abnormalities identified following a physical examination that, in the opinion of the investigator, would jeopardize the safety of the participant or interfere with study conduct if they took part in the study
Have a positive hepatitis C virus (HCV) antibody test
Show evidence of human immunodeficiency virus infection or positive human immunodeficiency virus antigen or antibodies
Show evidence of hepatitis B or positive hepatitis B surface antigen
Have alcohol intake that exceeds the recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator, or a positive ethanol test at screening or admission
Have smoked, or used tobacco or nicotine-containing products, in the 3 months prior to study intervention administration, or have a positive cotinine test at screening or admission
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenexa Clinic | Recruiting | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole |
| Drug |
Administered orally |
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| Itraconazole | Drug | Administered orally |
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| D010879 |
| Piperazines |