Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-01 @ 5:41 AM
Study NCT ID:
NCT06846528
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole in Healthy Participants
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD2389 When Administered Alone and in Combination With Itraconazole
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 this study is to assess the pharmacokinetics (PK) of AZD2389 when administered alone and in combination with itraconazole in healthy participants.
Detailed Description:
This study will be an open-label, fixed sequence, Drug-Drug Interaction (DDI) study consisting of 3 periods.
The study will comprise:
* A screening period of maximum 28 days
* Period 1
* Period 2
* Period 3
* A Follow-up Visit 7 to 14 days after the last PK sample has been collected.
The study will comprise:
* A screening period of maximum 28 days
* Period 1
* Period 2
* Period 3
* A Follow-up Visit 7 to 14 days after the last PK sample has been collected.
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?: