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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат LY4395089
  Administered orally
• Препарат Itraconazole
  Administered orally
• Препарат Itraconazole
  Administered orally

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Lenexa Clinic — Lenexa

Идентификаторы

NCT: NCT07592572 · 27808 · J6P-MC-NFAC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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