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

August 1, 2025 updated by: AstraZeneca

A Phase I, Open-label, Positron-Emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase I, open-label, non-randomised, single-centre study to determine brain distribution and exposure of [11C]savolitinib 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 [11C]savolitinib administered as an IV bolus at the start of PET imaging. Brain radioactivity measurements using PET/CT (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 [11C]savolitinib 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 technical/participant 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 [11C]savolitinib and PET examination

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Solna, Sweden, 171 64
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of injected radioactivity entering the brain (%ID) as %IDmax_brain
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Determine brain exposure of [11C]savolitinib following single, IV administration of a microdose in healthy adult volunteers
0-90 minutes post IV dose of [11C]savolitinib

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The following endpoint: Cmax_brain SUV
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: Tmax brain
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: AUCbrain 0-90
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: AUCplasma 0-90
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: Kp
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: Kp,uu
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: VT
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: Cmax_brain SUV
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: Tmax brain
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
0-90 minutes post IV dose of [11C]savolitinib
The following endpoints: AUCbrain 0-90
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
0-90 minutes post IV dose of [11C]savolitinib
The following endpoints: AUCplasma 0-90
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
0-90 minutes post IV dose of [11C]savolitinib
The following endpoints: Kp
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
0-90 minutes post IV dose of [11C]savolitinib
The following endpoints: Kp,uu
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
0-90 minutes post IV dose of [11C]savolitinib
The following endpoints: VT
Time Frame: 0-90 minutes post IV dose of [11C]savolitinib
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
0-90 minutes post IV dose of [11C]savolitinib

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with safety findings, AEs
Time Frame: Through study completion, up to 69 days (including screening period)
Provide additional safety and tolerability information for [11C]savolitinib IV and savolitinib oral administration (single dose)
Through study completion, up to 69 days (including screening period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonas Svensson, MD, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5084C00016
  • 2023-508334-34-00 (Other Identifier: EMA-CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal

Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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