Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05818514
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2023-03-15
Brief Title:
A PET Study to Determine Biodistribution and Binding Characteristics of 11CAZ14132516 in Healthy Participants
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase 0 Open Label Positron Emission Tomography Study to Assess the Biodistribution and Binding Characteristics of 11CAZ14132516 Following Administration to Healthy Participants
Status:
COMPLETED
Status Verified Date:
2023-07
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 purpose of this study is to measure the regional distribution and binding of 11CAZ14132516 to CCR9 in the abdomen using PET-CT examination in healthy participants
Study details include
The study duration will be up to 60 days
The IV radioligand 11CAZ14132516 will be administered at PET-CT examination Visit 2 for the pilot panel Visit 2 and 3 in the main panel
There will be 2 study visits for the pilot panel and 3 study visits for the main panel
Study details include
The study duration will be up to 60 days
The IV radioligand 11CAZ14132516 will be administered at PET-CT examination Visit 2 for the pilot panel Visit 2 and 3 in the main panel
There will be 2 study visits for the pilot panel and 3 study visits for the main panel
Detailed Description:
This is a Phase 0 first in human FIH open label radioligand development study in healthy male and female participants This radioligand development study will consist of two sequential panels
Pilot panel n up to 3 Main panel n up to 6
The purpose of the pilot panel is to perform initial PET-CT examinations using radioligand 11CAZ14132516 and to optimise the imaging protocol Up to 3 participants are planned to be included in this panel Participants will attend the PET unit for a single visit and will be administered a single intravenous microdose of 11CAZ14132516 10μg regardless of body weight approximately 400 MBq70kg radioactivity followed by a single PET-CT examination
The purpose of the main panel is to assess 11CAZ14132516 kinetics binding characteristics develop the quantitative analysis protocol and assess reproducibility of the analysis Six participants are planned to be included in this panel Participants will attend the PET unit for a baseline visit with administration of a single intravenous microdose of 11CAZ14132516 followed by a PET-CT examination Participants will return for a repeat visit 10 to14 days later where a second intravenous microdose of 11CAZ14132516 will be administered followed by a second PET-CT examination
Pilot panel n up to 3 Main panel n up to 6
The purpose of the pilot panel is to perform initial PET-CT examinations using radioligand 11CAZ14132516 and to optimise the imaging protocol Up to 3 participants are planned to be included in this panel Participants will attend the PET unit for a single visit and will be administered a single intravenous microdose of 11CAZ14132516 10μg regardless of body weight approximately 400 MBq70kg radioactivity followed by a single PET-CT examination
The purpose of the main panel is to assess 11CAZ14132516 kinetics binding characteristics develop the quantitative analysis protocol and assess reproducibility of the analysis Six participants are planned to be included in this panel Participants will attend the PET unit for a baseline visit with administration of a single intravenous microdose of 11CAZ14132516 followed by a PET-CT examination Participants will return for a repeat visit 10 to14 days later where a second intravenous microdose of 11CAZ14132516 will be administered followed by a second PET-CT examination
Study Oversight
Has Oversight DMC:
None
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?:
None