An Open-label, Nonrandomized, Single-dose, Parallel-group, Safety, Tolerance, and Pharmacokinetic Study of LOXO-305 Administered to Fasted Hepatically Impaired Male and Female Subjects and Fasted Matched-control Healthy Subjects

Eli Lilly and Company8 个研究点分布在 1 个国家目标入组 36 人开始时间: 2020年12月18日最近更新: 2025年1月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Eli Lilly and Company
入组人数: 36
试验地点: 8
主要终点: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Pirtobrutinib

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function and healthy participants. The side effects and tolerability of pirtobrutinib will also be evaluated. Participation could last about 46 days.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Participants with mild, moderate or severe hepatic impairment and healthy participants with normal hepatic function
•Males and females of non-childbearing potential.
•Within body mass index (BMI) range 18.5 to 40.0 kilograms per square meter (kg/m²).
•Participants will be in good health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), and clinical laboratory tests, as determined by the Investigator (or designee).
•Able to comply with all study procedures, including the 8-night stay at the Clinical Research Unit and follow-up phone call.

排除标准

•History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
•pancreatitis
•peptic ulcer disease
•intestinal malabsorption
•gastric reduction surgery
•history or presence of clinically significant cardiovascular disease.
•Participants with out-of-range, at-rest vital signs.
•Abnormal laboratory values determined to be clinically significant by the Investigator (or designee).
•Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
•Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
•Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) and through end of trial.
•History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
•Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
•Receipt of blood products within 2 months prior to Check-in (Day -1).
•Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the Investigator).

研究组 & 干预措施

Pirtobrutinib (Normal Hepatic Function)

Experimental

Participants received a single dose of Pirtobrutinib 200 milligrams (mg) administered orally on Day 1.

干预措施: Pirtobrutinib (Drug)

Pirtobrutinib (Mild Hepatic Impairment)

Experimental

Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1.

干预措施: Pirtobrutinib (Drug)

Pirtobrutinib (Moderate Hepatic Impairment)

Experimental

Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1.

干预措施: Pirtobrutinib (Drug)

Pirtobrutinib (Severe Hepatic Impairment)

Experimental

Participants received a single dose of Pirtobrutinib 200 mg administered orally on Day 1.

干预措施: Pirtobrutinib (Drug)