A Phase I, Open-Label, Randomized, 2-Way Crossover Study to Compare the PK of Pirtobrutinib (LOXO-305) Tablets

Eli Lilly and Company1 个研究点分布在 1 个国家目标入组 28 人开始时间: 2021年9月28日最近更新: 2025年1月13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: 28
试验地点: 1
主要终点: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) 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 compare two different formulations (mixtures) of pirtobrutinib (LOXO-305) in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will be collected. The study will last up to 65 days.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
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

•Males and females of non-childbearing potential.
•Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
•Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).

排除标准

•History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
•liver disease
•pancreatitis
•peptic ulcer disease
•intestinal malabsorption
•cholecystectomy
•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 Day
•Use or intention to use any prescription or over-the-counter medications within 14 days prior to 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), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).

研究组 & 干预措施

200 mg Pirtobrutinib (Sequence R/T)

Experimental

Period 1: Participants received a reference formulation (R) of oral pirtobrutinib 200 milligrams (mg) on day 1.

Period 2: Participants received a test formulation (T) of oral pirtobrutinib 200 mg on day 8.

There was a washout period of 7 days between the doses of pirtobrutinib.

干预措施: Pirtobrutinib (Drug)

200 mg Pirtobrutinib (Sequence T/R)

Experimental

Period 1: Participants received a test formulation (T) of oral pirtobrutinib 200 mg on day 1.

Period 2: Participants received a reference formulation (R) of oral pirtobrutinib 200 mg on day 8.

There was a washout period of 7 days between the doses of pirtobrutinib.

干预措施: Pirtobrutinib (Drug)

结局指标

主要结局

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib