A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Way Crossover, Pharmacokinetic Study to Evaluate the Relative Bioavailability of AB521 Tablet and Capsule Formulations and the Effect of Food on the Pharmacokinetics of the Tablet Formulation in Healthy Adult Volunteers

Arcus Biosciences, Inc.1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2023年8月21日最近更新: 2024年10月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Arcus Biosciences, Inc.
入组人数: 24
试验地点: 1
主要终点: Area Under the Plasma Drug Concentration-Time Curve (AUC)

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 primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan tablet versus the casdatifan capsule, and to evaluate the effect of food on the single-dose PK of casdatifan tablet in healthy adult volunteers.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 19 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on volunteer self-reporting
•Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilogram (kg)/square meter (m^2) at the screening visit, with body weight ≥ 45 kg
•Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the study physician
•Able to swallow multiple capsules and tablets
•Has adequate peripheral venous access

排除标准

•Has active neoplastic disease or history of neoplastic disease within 5 years of the screening visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
•Has abnormal liver enzyme test results or hematology values at the time of enrollment
•Has a history of additional risk factors for Torsades de pointes (example: heart failure, hypokalemia, family history of Long QT Syndrome)
•Malabsorption condition that would alter the absorption of orally administered medications at the discretion of the study physician
•Participation in another clinical study within 90 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study
•Note: Other protocol defined Inclusion/Exclusion criteria may apply.

研究组 & 干预措施

Casdatifan - Sequence ABC

Experimental

Participants will sequentially receive casdatifan capsules fasted (Treatment A), followed by casdatifan tablets fasted (Treatment B), followed by casdatifan tablets fed (Treatment C)

干预措施: casdatifan (Drug)

Casdatifan - Sequence BCA

Experimental

Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A

干预措施: casdatifan (Drug)

Casdatifan - Sequence CAB

Experimental

Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B

干预措施: casdatifan (Drug)