A Phase 1, Open Label, Randomized, 2-Way Crossover, 3-Period Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of LOXO-305 in Healthy Adult Subjects

Loxo Oncology, Inc.1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2020年2月6日最近更新: 2025年1月10日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Loxo Oncology, Inc.
入组人数: 10
试验地点: 1
主要终点: Pharmacokinetics (PK): Area Under the Concentration-time Curve From Hour 0 to 24 (AUC [0-24]) Hours of LOXO-305

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 learn about how food and a PPI (omeprazole) affect LOXO-305 in healthy participants. Participation could last about nine weeks.

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).
•Able to comply with all study procedures, including the 25-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:
•liver disease
•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), and Sponsor.
•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) through the end of the 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), 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

Treatment Sequence 1: ABC

Experimental

Period 1: Single oral dose of 200 milligram (mg) LOXO-305 (Fasted state) on Day 1 (Treatment A)
Period 2: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 8 (Treatment B)
Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)

A washout period of 7 days was maintained between each treatment period.

干预措施: LOXO-305 (Drug)

Treatment Sequence 1: ABC

Experimental

Period 1: Single oral dose of 200 milligram (mg) LOXO-305 (Fasted state) on Day 1 (Treatment A)
Period 2: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 8 (Treatment B)
Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)

A washout period of 7 days was maintained between each treatment period.

干预措施: Omeprazole (Drug)

Treatment Sequence 2: BAC

Experimental

Period 1: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 1 (Treatment B)
Period 2: Single oral dose of 200 mg LOXO-305 (Fasted state) on Day 8 (Treatment A)
Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)

A washout period of 7 days was maintained between each treatment period.

干预措施: LOXO-305 (Drug)

Treatment Sequence 2: BAC

Experimental

Period 1: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 1 (Treatment B)
Period 2: Single oral dose of 200 mg LOXO-305 (Fasted state) on Day 8 (Treatment A)
Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)

A washout period of 7 days was maintained between each treatment period.

干预措施: Omeprazole (Drug)

结局指标

主要结局

Pharmacokinetics (PK): Area Under the Concentration-time Curve From Hour 0 to 24 (AUC [0-24]) Hours of LOXO-305

时间窗: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post LOXO-305 dose

PK: AUC(0-24) hours of LOXO-305 is reported. AUC(0-24) was calculated by the linear trapezoidal method.

PK: Area Under the Concentration-time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of LOXO-305