Healthy VolunteersPhase 1NCT06348355
A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers
A Phase 1 study testing [11C]savolitinib and Savolitinib in people with Healthy Volunteers, run by AstraZeneca at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [11C]savolitinib and Savolitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSweden
- Study dates
- 12 Apr 2024to 24 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Body weight within 50.0 - 100.0 kg and body mass index within the range 18.0 - 30.0 kg/m2 (inclusive).
- Male or female with contraceptive use.
- 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.
- Female volunteers: Only females not of childbearing potential will be considered for enrollment in the study.
Who cannot join
- 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.
- Current evidence of SARS-CoV-2 infection with some exceptions applied on a case by case basis.
- Positive urine screen for drugs of abuse at screening visit, or known history of drug or alcohol abuse within the past year.
- 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.
- Any clinically significant abnormalities on 12-lead ECG, as judged by the investigator.
- Central nervous system infarction, infection or focal lesions of clinical significance on MRI scans.
Show all 12Show fewer
- Brain MRI abnormalities that would interfere with image analysis, as determined by the PI
- 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.
- Current significant major or unstable respiratory, heart, cerebrovascular, haematological, hepatic, renal, gastrointestinal diseases, or other major disease.
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Conditions
- Healthy Volunteers
- Being tested
- [11C]savolitinib, Savolitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]savolitinibDrug
Radiopharmaceutical; IMP; Sterile solution for IV injection, not more than 10 μg, single administration
SavolitinibDrug
IMP; 300 mg tablet, oral single administration
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | 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. Receives: Drug: [11C]savolitinib; Drug: Savolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of injected radioactivity entering the brain (%ID) as %IDmax_brain
Determine brain exposure of [11C]savolitinib following single, IV administration of a microdose in healthy adult volunteers
Measured: 0-90 minutes post IV dose of [11C]savolitinib
Secondary outcomes (14)
The following endpoint: Cmax_brain SUV
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: Tmax brain
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: AUCbrain 0-90
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: AUCplasma 0-90
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: Kp
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: Kp,uu
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: VT
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single, IV administration of a microdose
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: Cmax_brain SUV
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoint: Tmax brain
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoints: AUCbrain 0-90
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoints: AUCplasma 0-90
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoints: Kp
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoints: Kp,uu
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
Measured: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoints: VT
Estimate brain exposure of [11C]savolitinib in healthy adult volunteers after single oral dose of 300 mg of savolitinib
Measured: 0-90 minutes post IV dose of [11C]savolitinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start12 Apr 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonas Svensson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348355
- Sponsor's protocol ID
- D5084C00016
- Other IDs
- 2023-508334-34-00, 2023
- Status last verified
- Jul 2025
- First submitted
- 12 Mar 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Positron-Emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06348355
- Acronym / sponsor ID
- D5084C00016
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: [11C]savolitinib, Drug: SavolitinibHealthy 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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Body weight within 50.0 - 100.0 kg and body mass index within the range 18.0 - 30.0 kg/m2 (inclusive).
- Male or female with contraceptive use.
Key exclusion criteria (12 listed)
- 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.
- Current evidence of SARS-CoV-2 infection with some exceptions applied on a case by case basis.
- Positive urine screen for drugs of abuse at screening visit, or known history of drug or alcohol abuse within the past year.
- 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.
- Any clinically significant abnormalities on 12-lead ECG, as judged by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]savolitinibRadiopharmaceutical; IMP; Sterile solution for IV injection, not more than 10 μg, single administration | Drug | Healthy Volunteers |
| SavolitinibIMP; 300 mg tablet, oral single administration | Drug | Healthy Volunteers |
Primary outcome
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
14 secondary outcomes
The following endpoint: Cmax_brain SUV
Time frame: 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
The following endpoint: AUCbrain 0-90
Time frame: 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
The following endpoint: Kp
Time frame: 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
The following endpoint: VT
Time frame: 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
The following endpoint: Tmax brain
Time frame: 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
The following endpoints: AUCplasma 0-90
Time frame: 0-90 minutes post IV dose of [11C]savolitinib
The following endpoints: Kp
Time frame: 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
The following endpoints: VT
Time frame: 0-90 minutes post IV dose of [11C]savolitinib
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Healthy Volunteers
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Visual Attention, Object Recognition, and Eye Movements in Healthy Volunteers
Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Svensson, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [11C]savolitinib and Savolitinib in people with Healthy Volunteers, run by AstraZeneca at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.