Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 12:04 AM
Study NCT ID:
NCT06929260
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Ceralasertib on Drug X, Drug Y and Drug Z
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase I, Open-label, Fixed-sequence Study to Evaluate the Effect of Ceralasertib on Pharmacokinetics of Drug X, Drug Y and Drug Z in Participants With Advanced Solid Tumours
Status:
RECRUITING
Status Verified Date:
2025-11
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:
The study aims to assess the effect of ceralasertib on the pharmacokinetics (PK) of Drug X, Drug Y and Drug Z in participants with advanced solid tumours.
Detailed Description:
This is an open-label, 3-period fixed-sequence study. The study will comprise of -
* Screening Visit (Visit 1)
* Period 1 (Visit 2)
* Period 2 (Visit 3)
* Period 3 (Visit 4)
* Follow-up Visit (Visit 5)
A wash-out period of no less than 48 hours in each period.
* Screening Visit (Visit 1)
* Period 1 (Visit 2)
* Period 2 (Visit 3)
* Period 3 (Visit 4)
* Follow-up Visit (Visit 5)
A wash-out period of no less than 48 hours in each period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-516611-24-00 | OTHER | EU CT Number | View |