A Phase 1, Randomized, Open-Label, 2-part Study to Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor in Combination With Tezacaftor and Deutivacaftor in Healthy Adult Subjects

Vertex Pharmaceuticals Incorporated1 个研究点分布在 1 个国家目标入组 34 人开始时间: 2024年3月13日最近更新: 2025年9月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Vertex Pharmaceuticals Incorporated
入组人数: 34
试验地点: 1
主要终点: Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA

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 purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.

详细描述

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

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: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m^2), both inclusive
•A total body weight greater than (>)50 kg

排除标准

•History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
•Any condition possibly affecting drug absorption
•Female participants who are pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug
•Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug
•Other protocol defined Inclusion/Exclusion criteria may apply.

研究组 & 干预措施

Part A: Sequence 1

Experimental

Participants will receive VNZ/TEZ/D-IVA reference fixed dose combination (FDC) tablet in dosing period 1, then VNZ/TEZ/D-IVA test FDC granules dose level 1 in dosing period 2, and finally VNZ/TEZ/D-IVA test FDC granules dose level 2 in dosing period 3. A washout period of 14 days will be maintained between 3 dosing periods.