Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT05787002
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2023-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin.
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
An Open-label, 2-Period, 2-Sequence Cross-over Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2025-04
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 the study is to assess the effect of AZD0780 on the pharmacokinetics of rosuvastatin, and to assess the safety and tolerability of AZD0780 single dose, in healthy participants administered alone and in combination with rosuvastatin.
Detailed Description:
Eligible participants will be randomized, in a 1:1 ratio into 2 of the treatment arms. Each participant will receive 2 treatments in total throughout the study. The following treatments will be given in randomized order in fasting state:
Treatment A: single dose of rosuvastatin tablet alone
Treatment B: single dose of rosuvastatin tablet + AZD0780 tablet
The study will comprise:
1. A Screening Period of maximum 28 days.
2. Two Treatment Periods up to 3 days
3. A follow-up period of 10 to 12 days after the last administration of the study drug.
Following an overnight fast (minimum 10 hours) participants will receive either of the two treatments and will remain resident in the Clinical Unit until up to 48 hours after dosing of the study drug (up to Day 3).
The total duration of the study will be up to 9 weeks.
Treatment A: single dose of rosuvastatin tablet alone
Treatment B: single dose of rosuvastatin tablet + AZD0780 tablet
The study will comprise:
1. A Screening Period of maximum 28 days.
2. Two Treatment Periods up to 3 days
3. A follow-up period of 10 to 12 days after the last administration of the study drug.
Following an overnight fast (minimum 10 hours) participants will receive either of the two treatments and will remain resident in the Clinical Unit until up to 48 hours after dosing of the study drug (up to Day 3).
The total duration of the study will be up to 9 weeks.
Study Oversight
Has Oversight DMC:
False
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?: