Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348355
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2024-03-12
Brief Title:
A Positron-emission Tomography Study to Determine Brain Exposure of 11CSavolitinib in Healthy Volunteers
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase I Open-label Positron-Emission Tomography Study to Determine Brain Exposure of 11CSavolitinib in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-07
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 brain exposure of 11Csavolitinib in healthy volunteers
This study will determine brain exposure of 11Csavolitinib in up to 8 healthy volunteers under physiological conditions ie when the BBB is intact The study design allows up to 3 site visits Two PET examinations will be performed for each healthy volunteer The first PET examination will use IV administration of 11Csavolitinib The second PET examination using 11Csavolitinib will occur after a single oral dose of 300 mg of savolitinib PET image analysis will include kinetic compartment modelling using arterial input function and will generate a set of brain exposure parameters eg maximum ID maximum 11Csavolitinib concentration in brain partition coefficients between brain and plasma
This study will determine brain exposure of 11Csavolitinib in up to 8 healthy volunteers under physiological conditions ie when the BBB is intact The study design allows up to 3 site visits Two PET examinations will be performed for each healthy volunteer The first PET examination will use IV administration of 11Csavolitinib The second PET examination using 11Csavolitinib will occur after a single oral dose of 300 mg of savolitinib PET image analysis will include kinetic compartment modelling using arterial input function and will generate a set of brain exposure parameters eg maximum ID maximum 11Csavolitinib concentration in brain partition coefficients between brain and plasma
Detailed Description:
This is a Phase I open-label non-randomised single-centre study to determine brain distribution and exposure of 11Csavolitinib following IV bolus injections of a microdose in one cohort of healthy adult volunteers The study is composed of the following parts
Visit 1 Screening Screening including brain MRI within 45 days prior to PET imaging
Visit 2 PET examination Single microdose 10 μg of 11Csavolitinib administered as an IV bolus at the start of PET imaging Brain radioactivity measurements using PETCT radioactivity in brain and radioactivity measurements in arterial blood radioactivity in blood will be taken over a maximum of 90 minutes 300 mg savolitinib will be administered orally approximately 2 hours after the end of the first PET examination The second microdose of 11Csavolitinib will be administered as IV bolus at approximately 2 hours after the oral administration of savolitinib and a second PET examination will be conducted over 90 minutes PET2 examination can be performed on a separate day within 14 days after PET1 if it was not performed the same day due to technicalparticipant related reasons Oral savolitinib will be given on the same day as the second PET examination
Visit 3 Follow-up Telephone assessment 7 days 3 days after receiving the last microdose of 11Csavolitinib and PET examination
Visit 1 Screening Screening including brain MRI within 45 days prior to PET imaging
Visit 2 PET examination Single microdose 10 μg of 11Csavolitinib administered as an IV bolus at the start of PET imaging Brain radioactivity measurements using PETCT radioactivity in brain and radioactivity measurements in arterial blood radioactivity in blood will be taken over a maximum of 90 minutes 300 mg savolitinib will be administered orally approximately 2 hours after the end of the first PET examination The second microdose of 11Csavolitinib will be administered as IV bolus at approximately 2 hours after the oral administration of savolitinib and a second PET examination will be conducted over 90 minutes PET2 examination can be performed on a separate day within 14 days after PET1 if it was not performed the same day due to technicalparticipant related reasons Oral savolitinib will be given on the same day as the second PET examination
Visit 3 Follow-up Telephone assessment 7 days 3 days after receiving the last microdose of 11Csavolitinib and PET 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508334-34-00 | OTHER | EMA-CTIS | None |