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A Study to Evaluate Effects of Proton-pump Inhibitor on Acalabrutinib Capsule When Administered Orally With COCA-COLA in Healthy Participants

NCT04489797 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-10-30

No results posted yet for this study

Summary

This study is being conducted to support the clinical development of acalabrutinib in participants who need treatment with proton pump inhibitors while taking acalabrutinib.

Conditions

Interventions

DRUG

Acalabrutinib

Participants will receive single oral dose of acalabrutinib on day 1 as per the arms they are randomized.

DRUG

Rabeprazole

Participants will receive twice daily oral dose of 20 mg rabeprazole on days -3, -2, and -1.

Sponsors & Collaborators

  • Acerta Pharma BV

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Peter J. Winkle, MD FACP FACG CPI · Anaheim Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2020-08-28
Completion
2020-08-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04489797 on ClinicalTrials.gov