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

NCT06348355 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-08-06

No results posted yet for this study

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).

Conditions

  • Healthy Volunteers

Interventions

DRUG

[11C]savolitinib

Radiopharmaceutical; IMP; Sterile solution for IV injection, not more than 10 μg, single administration

DRUG

Savolitinib

IMP; 300 mg tablet, oral single administration

Sponsors & Collaborators

Principal Investigators

  • Jonas Svensson, MD, PhD · Karolinska Institutet

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06348355 on ClinicalTrials.gov