drugset / Trial / NCT04488016

A Study to Evaluate Relative Bioavailability, Proton Pump Inhibitor (PPI) (Rabeprazole) Effect, Food Effect and Particle Size Effect of New Acalabrutinib Tablet in Healthy Subjects

NCT04488016

Phase 1 Completed 54 enrolled AstraZeneca Acerta Pharma BV · collab
RandomizedSequentialOpen-labelTreatment

Summary

This study will be a 2-part, open-label, single-center relative bioavailability, PPI effect, food-effect and particle size effect randomized crossover study of acalabrutinib tablets in healthy subjects (males or females). The study will be divided in 2 study parts; following a review of the safety and Pharmacokinetics (PK) data from Part 1, the study is planned to be continued with Part 2.

Timeline

Start
2020-06-24
Primary completion
2021-01-20
Completion
2021-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Acalabrutinib Small molecule 100 mg Oral
Subject Rabeprazole Small molecule 20 mg

Indications