drugset / Trial / NCT06348355

A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers

NCT06348355

Phase 1 Completed 7 enrolled AstraZeneca
NaSingle-groupOpen-labelOther

Summary

The purpose of this study is to measure brain exposure of \[11C\]savolitinib in healthy volunteers. This study will determine brain exposure of \[11C\]savolitinib 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 \[11C\]savolitinib. The second PET examination using \[11C\]savolitinib 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 \[11C\]savolitinib concentration in brain, partition coefficients between brain and plasma).

Timeline

Start
2024-04-12
Primary completion
2024-06-24
Completion
2024-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Savolitinib Small molecule 300 mg Oral
Subject [11C]savolitinib Unknown 10 ug Intravenous
Subject [11C]savolitinib Unknown 400 mbq Intravenous

Indications

No indication recorded.