NCT07519525已完成1 期
A Phase 1, Open-label Study of the Absolute Bioavailability of [14C]-LY4064809 in Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- To determine the absolute bioavailability (F) of LY4064809 following administration of a single oral dose compared to an intravenous reference dose in healthy participants.
研究概览
简要总结
The purpose of this study is to determine in healthy participants the percentage of LY4064809 that enters bloodstream after oral administration. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 21 days, not including screening. Participants will remain in the clinical research center for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be healthy as shown by medical history, physical examination, laboratory tests and heart monitoring
- •Must have normal blood pressure and pulse rate
- •Must have a history of a minimum of 1 bowel movement per day
- •Must have body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m2)
- •Must be healthy men or healthy women who are not of childbearing potential
- •Healthy men with partners who can become pregnant must remain abstinent or use contraceptives consistent with local regulations
排除标准
- •Must not have a significant history or presence of metabolic disease, heart, liver, gallbladder, bile ducts, digestive, blood or nervous system disorders that could affect the way the body absorbs and processes the study drug
- •Must not have an abnormal electrocardiogram (ECG)
- •Must not have a history of major surgery within 30 days of entering study
- •Must not have a history of cancer within 5 years of screening
- •Must not have known allergies to LY4064809 or related compounds
- •Must not have history of multiple or severe drug reactions or allergies which required treatment with steroids or epinephrine
- •Must not have history or presence of psychiatric conditions that would prevent the participant from following study instructions.
- •Must not use medications, except acetaminophen within 14 days of the first dose of LY4064809 and during the clinic stay
- •Must not have participated in and been dosed in more than 2 radiolabeled drug studies in the last 12 months
- •Must not have had exposure to significant diagnostic, therapeutic or employment-related radiation within 12 months
- •Must not have participated in any other radiolabeled investigational study drug trial within 6 months prior to admission.
- •Must not show evidence of human immunodeficiency Virus (HIV) infection or positive HIV-1 and HIV-2 antibodies
- •Must not have evidence of Hepatitis C virus (HCV) infection or a positive HCV antibody test.
- •Must not have evidence of Hepatitis B virus (HBV) infection or a positive Hepatitis B surface antigen (HBsAg)
- •Must not have alcohol intake deemed significant by the investigator
- •Must not use tobacco, smoking-cessation products, e-cigarettes (nicotine and non-nicotine), or nicotine products within 90 days prior to LY4064809 administration and discharge from the clinical research unit (CRU) or early termination (ET)
研究组 & 干预措施
LY4064809
Experimental
干预措施: [14C]-LY4064809 (Drug)
LY4064809
Experimental
干预措施: LY4064809 (Drug)
结局指标
主要结局
To determine the absolute bioavailability (F) of LY4064809 following administration of a single oral dose compared to an intravenous reference dose in healthy participants.
时间窗: Baseline up to Day 14
次要结局
- Pharmacokinetics (PK): Plasma Maximum Concentration (Cmax) of LY4064809(Baseline up to Day 14)
- PK of Total Radioactivity: Plasma Area Under the Concentration Versus Time Curve (AUC) of [14C]-LY4064809(Baseline up to Day 14)
- Excretion and Recovery of Total Radioactivity and [14C] LY4064809 in Urine(Baseline up to Day 14)
- Excretion and Recovery of Total Radioactivity and [14C] LY4064809 in Feces(Baseline up to Day 14)
研究者
研究点 (1)
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