Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04564040
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2020-08-27
Brief Title:
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
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
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
Status Verified Date:
2020-12
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 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
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
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
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