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Recruiting NCT07592572

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

Phase I Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY4395089, Itraconazole, Itraconazole.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug LY4395089
    Administered orally
  • Drug Itraconazole
    Administered orally
  • Drug Itraconazole
    Administered orally

Primary outcome measures

  • Pharmacokinetics (PK): Area Under the Concentration versus Time Curve from 0 to infinity (AUC[0-∞]) of LY4395089 [Time frame: Baseline up to Day 15]
  • PK: Maximum Concentration (Cmax) of LY4395089 [Time frame: Baseline up to Day 15]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Lenexa Clinic — Lenexa

Identifiers

NCT: NCT07592572 · 27808 · J6P-MC-NFAC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗