NCT07592572

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
1mo left

Started May 2026

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
May 2026Jul 2026

Study Start

First participant enrolled

May 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 12, 2026

Last Update Submit

May 12, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

LY4395089

EXPERIMENTAL

LY4395089 administered orally

Drug: LY4395089

Itraconazole

EXPERIMENTAL

Itraconazole administered orally

Drug: Itraconazole

LY4395089 + Itraconazole

EXPERIMENTAL

LY4395089 and Itraconazole administered orally

Drug: LY4395089Drug: Itraconazole

Interventions

LY4395089DRUG

Administered orally

LY4395089LY4395089 + Itraconazole
ItraconazoleDRUG

Administered orally

Itraconazole

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lenexa Clinic

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • 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

Central Study Contacts

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

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 18, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)