NCT04435483

A Study of Acalabrutinib Suspension to Evaluate Relative Bioavailability and Proton-pump Inhibitor Effect in Healthy Volunteers

Phase I, Open-label, Single-dose, Sequential, Randomized, Crossover Study of Acalabrutinib Suspension Delivered Via Nasogastric Tube in Healthy Subjects to Evaluate Relative Bioavailability and Proton-pump Inhibitor (Rabeprazole) Effect

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (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 patients who are unable to swallow capsule and require nasogastric (NG) tube placement.

Detailed description

This is an open-label, single-center, randomized, 3-period, crossover study of acalabrutinib suspension administered via NG tube in healthy subjects to evaluate the relative bioavailability and proton-pump inhibitor (rabeprazole) effect. The study is divided in 3 periods. Period 1 of the study is designed to investigate the effect of proton-pump inhibitor on the pharmacokinetics (PK) of acalabrutinib suspension. Period 2 and 3 of the study are designed to investigate the bioavailability of acalabrutinib suspension relative to an oral capsule formulation.

Conditions

• Pharmacokinetics
• Bioavailability

Interventions

Type	Name	Description
DRUG	Acalabrutinib Treatment A	Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions. A single dose of 20 mg rabeprazole will be administered with 240 mL water, 2 hours prior to administration of acalabrutinib suspension. Treatment with rabeprazole 20 mg twice daily (with meals) will be started 3 days prior to the receiving the first dose of acalabrutinib suspension.
DRUG	Acalabrutinib Treatment B	Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions.
DRUG	Acalabrutinib Treatment C	Participants will receive a single dose of 100-mg acalabrutinib capsule, under fasted conditions. The acalabrutinib capsule will be administered with 240 mL of water.

Timeline

• Start date: 2020-05-22
• Primary completion: 2020-06-26
• Completion: 2020-06-26
• First posted: 2020-06-17
• Last updated: 2020-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study