RecruitingPhase 1NCT07592572

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

A Phase 1, Open-Label, Fixed-Sequence Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of LY4395089 in Healthy Participants

Sponsor

Eli Lilly and Company

Enrollment

14 participants

Start Date

May 20, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria4

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 Criteria17

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