NCT04564040

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 study is being conducted to support the clinical development of acalabrutinib in hospitalized patients who are unable to swallow acalabrutinib tablet or capsule due to respiratory failure, eg, they may require endotracheal intubation for ventilator support and nasogastric (NG) tube placement, and it is important to have a clinically acceptable method to administer acalabrutinib via NG tube. Part 1 of the study is designed to evaluate relative bioavailability by comparing the pharmacokinetic (PK) of AT suspension in water administered via NG tube with the PK of acalabrutinib capsule suspension in flat COCA-COLA administered via NG tube. Additionally, the PPI effect will be evaluated by comparing the PK of AT suspension in water administered via NG tube plus rabeprazole with the PK of AT suspension in water administered via NG tube. Part 2 of the study is designed to evaluate the effect of NG administration on AT by comparing the PK of AT suspension in water administered via NG tube with the PK of AT orally administered with water.

Detailed description

Part 1 of the study comprises: * A screening period of maximum 28 days. * Three treatment periods during which subjects will reside in the Clinical Unit from Day -2, Treatment Period 1 until at least 48 hours after dosing on Day 1, Treatment Period 3, ie, subjects will be discharged the morning of Day 3, Treatment Period 3. * A Follow-up Visit within 7 to 10 days after the last dose of acalabrutinib. There will be a minimum washout period of 4 days between treatment periods. Up to 20 subjects will be included to ensure at least 16 subjects are evaluable. Subjects will be randomized to one of 2 treatment sequences (ABC, BAC) and each subject will receive single doses of 3 treatments under fasted conditions. Part 2 of the study comprises: * A screening period of maximum 28 days. * Two treatment periods during which subjects will reside in the Clinical Unit from Day -2, Treatment Period 1 until at least 48 hours after dosing on Day 1, Treatment Period 2, ie, subjects will be discharged the morning of Day 3, Treatment Period 2. * A Follow-up Visit within 7 to 10 days after the last dose of acalabrutinib. There will be a minimum washout period of 4 days between treatment periods. Up to 20 subjects will be included to ensure at least 16 subjects are evaluable. Subjects will be randomized to one of 2 treatment sequences (DA, AD) and each subject will receive single doses of 2 treatments under fasted conditions.

Conditions

• Mantle Cell Lymphoma
• COVID-19

Interventions

Type	Name	Description
DRUG	Acalabrutinib Treatment A	Participants will receive 100 mg AT suspension in water via NG tube.
DRUG	Acalabrutinib Treatment B	Participants will receive 100 mg acalabrutinib capsule suspension via NG tube.
DRUG	Acalabrutinib Treatment C	Participants will receive 100 mg AT suspension in water via NG administration plus 20 mg rabeprazole.
DRUG	Acalabrutinib Treatment D	Participants will receive 100 mg AT orally.

Timeline

• Start date: 2020-10-12
• Primary completion: 2020-12-11
• Completion: 2020-12-11
• First posted: 2020-09-25
• Last updated: 2020-12-29

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study