A study in healthy subjects to assess bioavailability (proportion of a drug which enters the circulation to have an active effect) of acalabrutinib tablet and protonpump inhibitor effect (members of a class of medications that inhibits in gastric acid production) for Rabeprazole

Study identifier:D8223C00005

ClinicalTrials.gov identifier:NCT04564040

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Mantle Cell Lymphoma, COVID-19

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Acalabrutinib Treatment A, Acalabrutinib Treatment A, Acalabrutinib Treatment A, Acalabrutinib Treatment A, Acalabrutinib Treatment B, Acalabrutinib Treatment B, Acalabrutinib Treatment B, Acalabrutinib Treatment B, Acalabrutinib Treatment C, Acalabrutinib Treatment C, Acalabrutinib Treatment C, Acalabrutinib Treatment C, Acalabrutinib Treatment D, Acalabrutinib Treatment D, Acalabrutinib Treatment D, Acalabrutinib Treatment D

Sex

All

Actual enrollment

20

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 12 Oct 2020
Primary Completion Date: 11 Dec 2020
Study Completion Date: 11 Dec 2020

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2021 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Parexel International

Inclusion and exclusion criteria