Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04488016
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2020-06-23
Brief Title:
A Study to Evaluate Relative Bioavailability Proton Pump Inhibitor PPI Rabeprazole Effect Food Effect and Particle Size Effect of New Acalabrutinib Tablet in Healthy Subjects
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A 2-Part Phase I Open-label Single-Dose Sequential Randomized Crossover Study of New Acalabrutinib Tablet in Healthy Subjects to Evaluate Relative Bioavailability Proton Pump Inhibitor Rabeprazole Effect Food Effect and Particle Size Effect
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be a 2-part open-label single-center relative bioavailability PPI effect food-effect and particle size effect randomized crossover study of acalabrutinib tablets in healthy subjects males or females The study will be divided in 2 study parts following a review of the safety and Pharmacokinetics PK data from Part 1 the study is planned to be continued with Part 2
Detailed Description:
The study will be divided in 2 study parts Part 1 of this study will be an open-label 3-treatment-period 4-treatment single-center relative bioavailability PPI effect and food-effect randomized crossover study of a new acalabrutinib tablet in healthy subjects males or females
The relative bioavailability part of Study Part 1 is designed to investigate the PK of the acalabrutinib tablet compared with the PK of acalabrutinib capsule when administered as a single dose with water under the fasted condition 10 hours The PPI effect part of Study Part 1 is designed to compare the PK of acalabrutinib tablet with or without coadministration of the PPI rabeprazole The food-effect part of Study Part 1 is designed to compare the PK of acalabrutinib tablet under fed and fasted conditions For each subject a SmartPill will be administered with 120 mL of still water followed immediately by a single oral dose of acalabrutinib tablet Treatment B C or D or acalabrutinib capsule Treatment A administered with 120 mL of still water
Study Part 1 will comprise
A screening period of maximum 28 days
Three treatment periods during which subjects will be resident from prior to the evening meal the night before dosing with Investigational medicinal product IMP Day -1 until at least 48 hours after dosing discharged on the morning of Day 3 and
A Follow-up Visit within 7 to 10 days There will be a minimum washout period of at least 7 days between each acalabrutinib administration
A decision to continue with Study Part 2 will be made following a review of the preliminary data for relative bioavailability acalabrutinib tablet versus acalabrutinib capsule food effect PPI effect and safety observed in Part 1
Part 2 of this study will be an open-label 4-treatment-period 4-treatment single-center relative bioavailability randomized crossover study to determine the effect of particle size on the PK of a single dose of acalabrutinib tablet in healthy subjects males or females
This relative bioavailability study is designed to investigate the PK of acalabrutinib tablets with various drug substance particle size distributions and the PK of acalabrutinib solution at a single oral dose of 100 mg under the fasted condition 10 hours
Study Part 2 will comprise
A screening period of maximum 28 days
Four treatment periods during which subjects will be resident prior to the evening meal the night before dosing with IMP Day -1 until at least 48 hours after dosing discharged on the morning of Day 3 and
A Follow-up Visit within 7 to 10 days There will be a minimum washout period of at least 3 days between each acalabrutinib administration
The relative bioavailability part of Study Part 1 is designed to investigate the PK of the acalabrutinib tablet compared with the PK of acalabrutinib capsule when administered as a single dose with water under the fasted condition 10 hours The PPI effect part of Study Part 1 is designed to compare the PK of acalabrutinib tablet with or without coadministration of the PPI rabeprazole The food-effect part of Study Part 1 is designed to compare the PK of acalabrutinib tablet under fed and fasted conditions For each subject a SmartPill will be administered with 120 mL of still water followed immediately by a single oral dose of acalabrutinib tablet Treatment B C or D or acalabrutinib capsule Treatment A administered with 120 mL of still water
Study Part 1 will comprise
A screening period of maximum 28 days
Three treatment periods during which subjects will be resident from prior to the evening meal the night before dosing with Investigational medicinal product IMP Day -1 until at least 48 hours after dosing discharged on the morning of Day 3 and
A Follow-up Visit within 7 to 10 days There will be a minimum washout period of at least 7 days between each acalabrutinib administration
A decision to continue with Study Part 2 will be made following a review of the preliminary data for relative bioavailability acalabrutinib tablet versus acalabrutinib capsule food effect PPI effect and safety observed in Part 1
Part 2 of this study will be an open-label 4-treatment-period 4-treatment single-center relative bioavailability randomized crossover study to determine the effect of particle size on the PK of a single dose of acalabrutinib tablet in healthy subjects males or females
This relative bioavailability study is designed to investigate the PK of acalabrutinib tablets with various drug substance particle size distributions and the PK of acalabrutinib solution at a single oral dose of 100 mg under the fasted condition 10 hours
Study Part 2 will comprise
A screening period of maximum 28 days
Four treatment periods during which subjects will be resident prior to the evening meal the night before dosing with IMP Day -1 until at least 48 hours after dosing discharged on the morning of Day 3 and
A Follow-up Visit within 7 to 10 days There will be a minimum washout period of at least 3 days between each acalabrutinib administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None