A Study of Itraconazole and LY4395089 in Healthy Participants
This study is looking at how a medication called itraconazole affects another medication called LY4395089 in healthy volunteers. Researchers want to understand how your body processes LY4395089 when itraconazole is also taken. They will measure the levels of LY4395089 in your blood over time to see how it's absorbed and cleared from your system. You might be able to join if you are a healthy adult between 18 and 64 years old with a BMI between 18.0 and 32.0. The study aims to enroll 14 participants. The current status of recruitment is unclear.
- Study design
- This is an interventional study involving 14 healthy participants. It is not specified if it is randomized or blinded.
- What's involved
- You would have fifteen inpatient stays at a clinical research unit. The study will last about 2 weeks and involve blood tests.
- Compensation
- Not stated in the trial record.
- Follow-up
- Blood tests to measure drug levels will be taken from baseline up to Day 15.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07592572
A Study of the Effects of Itraconazole on LY4395089 in Healthy Participants
Completed
PHASE1Ages 18–64InterventionalBasic scienceEli Lilly and Company
~14 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:LY4395089Itraconazole
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from 0 to infinity (AUC[0-∞]) of LY4395089
Measured over Baseline up to Day 15
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesKansas1
Study leadership
- 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) · STUDY_DIRECTOR · Eli Lilly and Company
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from 0 to infinity (AUC[0-∞]) of LY4395089Baseline up to Day 15
- PK: Maximum Concentration (Cmax) of LY4395089Baseline up to Day 15