Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554821
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
A Study to Investigate the Effect of Oral Ticagrelor on the Pharmacokinetics of Oral Rosuvastatin When Given in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Randomised Parallel-group Fixed-sequence Study to Assess the Effect of Oral Ticagrelor on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2024-10
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:
The purpose of this study is to measure the effect of ticagrelor on the pharmacokinetics PK of rosuvastatin in healthy participants
Detailed Description:
This study will be conducted at a single Clinical Unit It includes 2 parallel arms one for each rosuvastatin dose and 2 treatment periods
The study will comprise
A Screening Period of maximum 28 days
Period 1 It will start on Day -1 A single dose of rosuvastatin dose 1 or dose 2 will be administered on Day 1 followed by PK sampling of rosuvastatin for 96 hours Participants will be admitted to the Clinical Unit on Study Day -1 Period 1 will end on Study Day 5
Period 2 It will start on Study Day 6 A second single dose of rosuvastatin dose 1 or dose 2 will be administered on Day 6 followed by PK sampling of rosuvastatin for 120 hours Ticagrelor 90 mg twice a day will be started on Day 6 administered concomitantly with rosuvastatin and administered through Day 10 Period 2 will end on Study Day 12
A Follow-up Visit 4 to 7 days after discharge
The study will comprise
A Screening Period of maximum 28 days
Period 1 It will start on Day -1 A single dose of rosuvastatin dose 1 or dose 2 will be administered on Day 1 followed by PK sampling of rosuvastatin for 96 hours Participants will be admitted to the Clinical Unit on Study Day -1 Period 1 will end on Study Day 5
Period 2 It will start on Study Day 6 A second single dose of rosuvastatin dose 1 or dose 2 will be administered on Day 6 followed by PK sampling of rosuvastatin for 120 hours Ticagrelor 90 mg twice a day will be started on Day 6 administered concomitantly with rosuvastatin and administered through Day 10 Period 2 will end on Study Day 12
A Follow-up Visit 4 to 7 days after discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None