Available IPD datapackage for study 'A 2-Part, Phase I, Open-label, Single-dose, Sequential, Randomized, Crossover Study of Acalabrutinib Tablet Suspension Delivered Via Nasogastric Tube in Healthy Subjects to Evaluate Relative Bioavailability and Proton-pump Inhibitor (Rabeprazole) Effect'
收藏DataCite Commons2025-07-07 更新2026-05-07 收录
下载链接:
https://search.vivli.org/doiLanding/dataPackages/PR00008228.0
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资源简介:
This Phase 1 study is being conducted to support the clinical development of acalabrutinib in
hospitalized patients who are unable to swallow acalabrutinib tablet or capsule due to
respiratory failure, eg, they may require endotracheal intubation for ventilator support and
nasogastric (NG) tube placement, and it is important to have a clinically acceptable method
to administer acalabrutinib via NG tube.
Part 1 of the study is designed to evaluate relative bioavailability by comparing the
pharmacokinetic (PK) of AT suspension in water administered via NG tube with the PK of
acalabrutinib capsule suspension in flat COCA-COLA administered via NG tube. Additionally,
the PPI effect will be evaluated by comparing the PK of AT suspension in water administered
via NG tube plus rabeprazole with the PK of AT suspension in water administered via NG tube.
Part 2 of the study is designed to evaluate the effect of NG administration on AT by
comparing the PK of AT suspension in water administered via NG tube with the PK of AT orally
administered with water.
提供机构:
Vivli
创建时间:
2025-07-07



