Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04788641
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2021-03-05
Brief Title:
Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Two-Cohort Randomised Sequence Cross-over Open-label Study to Assess the Effect of a Single Dose of Sodium Zirconium Cyclosilicate SZC on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be an open-label randomised sequence 2-period 2-cohort 2-treatment in each cohort cross-over study in healthy subjects males and females of non-childbearing potential performed at a single study centre
Detailed Description:
The study will comprise
A screening period of maximum 28 days
Two treatment periods
Treatment Period 1 starts with admission to the Clinical Unit on Day -1 followed by dosing on Day 1 with the assigned treatment A B C or D as per assigned cohort and treatment sequence followed by a washout period of at least 14 days
Treatment Period 2 starts with admission to Clinical Unit on Day -1 followed by dosing on Day 1 with cross-over treatment as per assigned cohort followed by a follow-up period of 7 to 10 days
A follow-up visitearly termination visit at 7 to 10 days after the last investigation medicinal product IMP administration
Subjects will be assigned to either Cohort 1 tacrolimus or to Cohort 2 cyclosporin Each cohort will have 2 treatment periods Subjects in each cohort will be randomly assigned to one of 2 treatment sequences ABBA or CDDC where
Treatment A Tacrolimus
Treatment B Tacrolimus SZC
Treatment C Cyclosporin
Treatment D Cyclosporin SZC
A screening period of maximum 28 days
Two treatment periods
Treatment Period 1 starts with admission to the Clinical Unit on Day -1 followed by dosing on Day 1 with the assigned treatment A B C or D as per assigned cohort and treatment sequence followed by a washout period of at least 14 days
Treatment Period 2 starts with admission to Clinical Unit on Day -1 followed by dosing on Day 1 with cross-over treatment as per assigned cohort followed by a follow-up period of 7 to 10 days
A follow-up visitearly termination visit at 7 to 10 days after the last investigation medicinal product IMP administration
Subjects will be assigned to either Cohort 1 tacrolimus or to Cohort 2 cyclosporin Each cohort will have 2 treatment periods Subjects in each cohort will be randomly assigned to one of 2 treatment sequences ABBA or CDDC where
Treatment A Tacrolimus
Treatment B Tacrolimus SZC
Treatment C Cyclosporin
Treatment D Cyclosporin SZC
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000515-68 | EUDRACT_NUMBER | None | None |