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Study identifier: NCT07592572 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Recruiting

A Study of the Effects of Itraconazole on LY4395089 in Healthy Participants

Condition: Healthy  ·  Sponsor: Eli Lilly and Company

PhasePhase 1
Planned participants14
Who can joinAll sexes, 18 Years to 64 Years
Healthy volunteersYesCheck eligibility criteria ↓
WhereLenexa, Kansas, United States

Interested? Contact the study team ↓

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or  ·  1-317-615-4559  ·  LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact  ·  clinical_inquiry_hub@lilly.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs) * Have a body mass index (BMI) within the range 18.0 to 32.0 kilogram per square meter (kg/m²) (inclusive) * Individuals assigned male at birth (AMAB) or assigned female at birth (AFAB) who are individual not of childbearing potential (INOCBP) Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies * Are reliable and willing to make themselves available for the duration of the study and are willing to follow clinical research unit (CRU)-specific study procedures Exclusion Criteria: * Have a significant history or presence of the following conditions: * rheumatologic * Cardiovascular (CV), including congestive heart failure * respiratory * hepatic, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum total bilirubin level (TBL) above 1.25 × upper limit of normal (ULN) per the laboratory's reference range at screening or admission * renal * gastrointestinal (GI) * endocrine, including Cushing syndrome, hyperthyroidism, and hyperaldosteronism * hematological, or * neurological disorders * 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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (1)

Lenexa ClinicLenexa, Kansas, United StatesRecruiting

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Lenexa

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