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

Sponsor
AstraZeneca
Study ID
NCT06348355
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
50 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • [11C]savolitinib — DRUG
    Radiopharmaceutical; IMP; Sterile solution for IV injection, not more than 10 μg, single administration
  • Savolitinib — DRUG
    IMP; 300 mg tablet, oral single administration

Study Details

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).

Key Dates

Start date
Apr 12, 2024
Status verified
Jul 2025
Primary completion
Jun 24, 2024
Completion
Jun 24, 2024

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Healthy Volunteers
    Healthy volunteers will undergo two PET examinations and will receive 2 single IV doses of \[11C\]savolitinib (total ≤ 20 µg) and radioactivity of 400 ± 10% mBq/70 kg/per PET-CT examination, with total radiation exposure during the study of 3.86 mSv. Healthy volunteers will receive a single 300 mg dose of oral savolitinib approximately 2 hours after the end of the first PET examination and approximately 2 hours before the second IV dose of \[11C\]savolitinib. The second PET examination can be performed on a separate day, within 14 days after the first PET examination. Oral savolitinib will be given on the same day as the second PET examination.

Primary Outcome Measure

Percentage of injected radioactivity entering the brain (%ID) as %IDmax_brain [ Time Frame: 0-90 minutes post IV dose of [11C]savolitinib ]

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