NCT04489797

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

A Phase I, Open-label, Randomized, Single-dose Study of Acalabrutinib in Healthy Subjects to Evaluate the Effect of Proton-pump Inhibitor (Rabeprazole) on Acalabrutinib Capsule When Administered Orally With COCA-COLA

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an open-label, single-center, randomized study in healthy participants to evaluate the effect of proton-pump inhibitors (rabeprazole; PPI) on acalabrutinib 100-mg capsule dosed orally with COCA-COLA. Participants will receive a single dose of acalabrutinib alone or with rabeprazole, and pharmacokinetic (PK), safety and tolerability will be assessed.

Conditions

• Infectious Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-20
• Primary completion: 2020-08-28
• Completion: 2020-08-28
• First posted: 2020-07-28
• Last updated: 2020-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study