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 B, Acalabrutinib Treatment C, 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