Pharmacokinetics Clinical Trial
Official title:
Phase I, Open-label, Single-dose, Sequential, Randomized, Crossover Study of Acalabrutinib Suspension Delivered Via Nasogastric Tube in Healthy Subjects to Evaluate Relative Bioavailability and Proton-pump Inhibitor (Rabeprazole) Effect
This study is being conducted to support the clinical development of acalabrutinib in patients who are unable to swallow capsule and require nasogastric (NG) tube placement.
This is an open-label, single-center, randomized, 3-period, crossover study of acalabrutinib
suspension administered via NG tube in healthy subjects to evaluate the relative
bioavailability and proton-pump inhibitor (rabeprazole) effect.
The study is divided in 3 periods.
Period 1 of the study is designed to investigate the effect of proton-pump inhibitor on the
pharmacokinetics (PK) of acalabrutinib suspension. Period 2 and 3 of the study are designed
to investigate the bioavailability of acalabrutinib suspension relative to an oral capsule
formulation.
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