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Recruiting

NCT Number: NCT07592572

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

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.

Recruiting

Interested in participating?

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lenexa Clinic

Lenexa, Kansas, 66219, United States

Location status: Recruiting

Location contact

Patrick Yao

PRINCIPAL_INVESTIGATOR

CONTACT

913-574-6457

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4395089

Drug

Administered orally

Itraconazole

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from 0 to infinity (AUC[0-∞]) of LY4395089

    Time frame: Baseline up to Day 15

  2. PK: Maximum Concentration (Cmax) of LY4395089

    Time frame: Baseline up to Day 15

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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