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

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Healthy Volunteers

Interventions: [11C]savolitinib, Savolitinib

Countries: Sweden

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).

Eligibility overview

Sex: ALL

Age: 50 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Healthy volunteers must be ≥ 50 to 65 years of age inclusive, at the time of signing the informed consent form and capable of giving informed consent.
2. Body weight within 50.0 - 100.0 kg and body mass index within the range 18.0 - 30.0 kg/m2 (inclusive).
3. Male or female with contraceptive use.

a. Male volunteers: (i) does not wish to father any children in the 6 months after the study follow-up visit and must use condoms and spermicide with sexual partners who are pregnant or who could become pregnant from the time of dosing until 6 months after savolitinib administration.

b. Female volunteers: Only females not of childbearing potential will be considered for enrollment in the study.

Exclusion Criteria:

1. Having known or suspected systemic infection (eg, hepatitis B virus, hepatitis C virus, human immunodeficiency virus, tuberculosis), including previous or on-going infectious or autoimmune disease.
2. Current evidence of SARS-CoV-2 infection with some exceptions applied on a case by case basis.
3. Positive urine screen for drugs of abuse at screening visit, or known history of drug or alcohol abuse within the past year.
4. Any factors that may increase the risk of QTcF prolongation such as congenital of familiar long QT syndrome, chronic hypokalemia not correctable with supplements etc.
5. Any clinically significant abnormalities on 12-lead ECG, as judged by the investigator.
6. Central nervous system infarction, infection or focal lesions of clinical significance on MRI scans.
7. Brain MRI abnormalities that would interfere with image analysis, as determined by the PI
8. Presence of significant abnormalities in the medical history or physical examination or laboratory tests at screening that may interfere with the study or present a safety risk.
9. Current significant major or unstable respiratory, heart, cerebrovascular, haematological, hepatic, renal, gastrointestinal diseases, or other major disease.
10. Any concomitant medications known to be associated with Torsades de Pointes, potent inducers of cytochrome P450 3A4 (CYP3A4), strong inhibitor of CYP1A2, inhibitors or inducers of P-gp.
11. Participation in a research PET or PET/CT study in the previous 12 months, and as per the judgement of the PI participation in this study will not expose the volunteer to radiation in excess of internationally accepted limit.
12. History of autoimmune disease, severe/ongoing allergy or atopy, or history of hypersensitivity to drugs with a similar chemical structure or class to \[11C\]savolitinib/savolitinib or the excipients of \[11C\]savolitinib/savolitinib.

Locations (1)

Solna, Sweden