HTX-019（静脉用阿瑞匹坦）和福沙匹坦在健康受试者中的安全性。
Safety of HTX-019 (intravenous aprepitant) and fosaprepitant in healthy subjects.
机构信息
Pharmaceutical & Translational Sciences, Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.
Clinical Operations, Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.
出版信息
Future Oncol. 2018 Nov;14(27):2849-2859. doi: 10.2217/fon-2018-0311. Epub 2018 Jun 6.
AIM
Evaluate safety of HTX-019, a novel polysorbate 80- and synthetic surfactant-free intravenous formulation of neurokinin 1 receptor antagonist aprepitant for chemotherapy-induced nausea and vomiting.
METHODS
Two open-label, randomized, two-way crossover studies evaluated treatment-emergent adverse events (TEAEs) in 200 healthy subjects. Subjects received HTX-019 130 mg (30-min infusion) and fosaprepitant 150 mg (20- or 30-min infusion), with ≥7-day washout between doses.
RESULTS
Less than or equal to 30 min after start of infusion, TEAEs occurred in 5 (3%) HTX-019 and 30 (15%) fosaprepitant recipients. No HTX-019 recipients had infusion-site adverse events, versus 15 (8%) fosaprepitant recipients. Treatment-related dyspnea occurred in one HTX-019 and six fosaprepitant recipients. No severe/serious TEAEs occurred; all TEAEs resolved.
CONCLUSION
HTX-019 may provide a safer aprepitant formulation than fosaprepitant for chemotherapy-induced nausea and vomiting prevention.
目的
评估 HTX-019 的安全性，这是一种新型的聚山梨酯 80 和合成表面活性剂-free 的神经激肽 1 受体拮抗剂阿瑞匹坦静脉制剂，用于预防化疗引起的恶心和呕吐。
方法
两项开放标签、随机、双交叉研究评估了 200 例健康受试者的治疗中出现的不良事件（TEAEs）。受试者接受 HTX-019 130mg（30 分钟输注）和 fosaprepitant 150mg（20 或 30 分钟输注），两次给药之间有≥7 天的洗脱期。
结果
输注开始后≤30 分钟，5 例（3%）HTX-019 组和 30 例（15%）fosaprepitant 组发生 TEAEs。无 HTX-019 组发生输注部位不良反应，而 fosaprepitant 组有 15 例（8%）。1 例 HTX-019 组和 6 例 fosaprepitant 组出现治疗相关呼吸困难。无严重/严重 TEAEs 发生；所有 TEAEs 均已解决。
结论
与 fosaprepitant 相比，HTX-019 可能为预防化疗引起的恶心和呕吐提供一种更安全的阿瑞匹坦制剂。
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