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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4395089 		LY4395089 administered orally
  • Drug: LY4395089
    Administered orally
  • Drug: Itraconazole
    Administered orally
Experimental
Itraconazole 		Itraconazole administered orally
  • Drug: Itraconazole
    Administered orally
  • Drug: Itraconazole
    Administered orally
Experimental
LY4395089 + Itraconazole 		LY4395089 and Itraconazole administered orally
  • Drug: LY4395089
    Administered orally
  • Drug: Itraconazole
    Administered orally

Recruiting Locations

Lenexa Clinic
Lenexa, Kansas 66219
Contact:
913-574-6457

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.