Healthy VolunteersEarly Phase 1NCT05818514
A PET Study to Determine Biodistribution and Binding Characteristics of [11C]AZ14132516 in Healthy Participants
A Early Phase 1 study testing [11C]AZ14132516 in people with Healthy Volunteers, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of this study is to measure the regional distribution and binding of [11C]AZ14132516 to CCR9 in the abdomen using PET-CT examination in healthy participants. Study details include: The study duration will be up to 60 days. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [11C]AZ14132516
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- 27 Apr 2023to 11 Jul 2023
- Phase
- Early 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Informed Consent
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
- Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.
- Participants ≥ 20 to 65 years of age inclusive, at the time of signing the ICF.
- Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory parameters and ECG performed before first administration of investigational product.
- Body weight within 50.0 to 100.0 kg and body mass index within the range 18.0 to 30.0 kg/m2 (inclusive).
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- Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Female participants:
- In this study:
- WOCBP must have a negative pregnancy test at screening and before PET examination (all premenopausal women, or in case when menstrual status cannot be ascertained in women under the age of 55 years).
- If sexually active with a non-sterilised male partner, must use at least one highly effective method of birth control during the study period and for 7 days following last radioligand administration.
- It is strongly recommended that non-sterilised male partners of female participants of childbearing potential use a male condom plus spermicide during the study period.
- Female participants must not breastfeed and must not donate or retrieve ova for their own use during the study period and for 7 days following last radioligand administration.
- Male participants:
- Non-sterilised male participants who are sexually active with a female partner of childbearing potential must use a condom with spermicide during the study period and for 7 days following last radioligand administration. It is strongly recommended that female partners of male participants also use at least one highly effective method of contraception throughout this period. In addition, male participants must refrain from fathering a child or donating sperm during the study period and for 7 days following last radioligand administration.
Who cannot join
- Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, hematological disease, hepatic disease, renal disease, gastrointestinal disease, or other major diseases.
- Participants with unstable hypertension (as judged by the Investigator) or symptomatic hypotension, history of pre-syncope or syncope due to orthostatic hypotension and/or induced by change of posture (orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg).
- Significant abnormalities on the clinical examination, including neurological and physical examination, vital signs, ECG and clinical.
- Chemistry, hematology, or urine analysis results that may interfere with the study or present a safety risk to the patient.
- Abnormal vital signs, after 10 minutes of supine rest as judged by the PET centre physician. As a guide, any readings outside the following should be considered in the evaluation:
- systolic blood pressure (BP) ≥ 140 mmHg
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- diastolic BP ≥ 90 mmHg
- heart rate ≤ 35 bpm or ≥ 100 bpm The inclusion of participants meeting the above criteria may be decided on a case-by case basis by PET centre physician.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This may include participants with any of the following:
- PR (PQ) interval prolongation of clinical significance as judged by the Investigator
- Intermittent second or third degree AV block (AV block II Mobitz type 1, Wenchebach, while asleep or in deep rest is not disqualifying)
- Incomplete, full, or intermittent bundle branch block (QRS ≤ 110 ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy)
- Abnormal T wave morphology, particularly in the protocol-defined primary lead
- Prolonged QTcF ≥ 470 ms or shortened QTcF ≤ 340 ms or a family history of long QT syndrome.
- The inclusion of participants meeting the above criteria may be decided on a case-by case basis by PET centre physician.
- Known or suspected systemic infection (eg, hepatitis B virus, hepatitis C virus, HIV and tuberculosis), including previous or ongoing infectious or autoimmune disease.
- Participants must abstain from taking prescription or non-prescription drugs (including vitamins, recreational drugs, and dietary or herbal supplements) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study intervention until completion of the follow-up visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
- Current drug abuse or dependence or positive screen for drugs of abuse at screening visit.
- Participants on anticoagulant treatment.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Suffers from claustrophobia that limits the ability to undergo the scanning procedure.
- Participant has abnormal blood flow confirmed by a negative Allen's test in both hands at screening.
- Blood donation within 1 month of screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to screening.
- Positive SARS-CoV-2 rapid antigen test at screening
- Any other reason that, in the study PI opinion, prohibits the inclusion of the participants into the study.
- Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 0 Open Label Positron Emission Tomography Study to Assess the Biodistribution and Binding Characteristics of [11C]AZ14132516 Following Administration to Healthy Participants
The purpose of this study is to measure the regional distribution and binding of [11C]AZ14132516 to CCR9 in the abdomen using PET-CT examination in healthy participants.
Study details include:
The study duration will be up to 60 days.
The IV radioligand [11C]AZ14132516 will be administered at PET-CT examination: Visit 2 for the pilot panel; Visit 2 and 3 in the main panel.
There will be 2 study visits for the pilot panel and 3 study visits for the main panel.
Read the detailed description
This is a Phase 0, first in human (FIH) open label radioligand development study in healthy male and female participants. This radioligand development study will consist of two sequential panels:
Pilot panel (n = up to 3) Main panel (n = up to 6)
The purpose of the pilot panel is to perform initial PET-CT examinations using radioligand [11C]AZ14132516 and to optimise the imaging protocol. Up to 3 participants are planned to be included in this panel. Participants will attend the PET unit for a single visit and will be administered a single intravenous microdose of [11C]AZ14132516 (≤ 10μg regardless of body weight, approximately 400 MBq/70kg radioactivity) followed by a single PET-CT examination.
The purpose of the main panel is to assess [11C]AZ14132516 kinetics, binding characteristics, develop the quantitative analysis protocol and assess reproducibility of the analysis. Six participants are planned to be included in this panel. Participants will attend the PET unit for a baseline visit with administration of a single intravenous microdose of [11C]AZ14132516 followed by a PET-CT examination. Participants will return for a repeat visit 10 to14 days later where a second intravenous microdose of [11C]AZ14132516 will be administered followed by a second PET-CT examination.
- Conditions
- Healthy Volunteers
- Being tested
- [11C]AZ14132516
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]AZ14132516Drug
Also called No other names
Injection of radioligand for PET examinations
| Study group | Role | What they receive |
|---|---|---|
| [11C]AZ14132516 | Experimental | Pilot panel: up to 3 participants to complete 1 PET examination each during the course of the study Main panel: up to 6 participants to complete 2 PET examinations each during the course of the study Receives: Drug: [11C]AZ14132516 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV and SUVR in abdominal regions of interest
Standardized uptake value (SUV) is the radioactivity concentration in given region of interest normalized for injected radioactivity and body weight.
Standardised uptake value ratio (SUVR) is the ratio of SUV in a given region of interest to a reference region without significant radioligand uptake
Measured: Immediately following administration of radioligand
Secondary outcomes (2)
Absolute percentage differences of SUV and SUVR, and intraclass correlation coefficients, in regions of interest between two test-retest PET examinations
Measured: 10-14 days following initial administration of radioligand
Number of participants with safety findings, AEs
Measured: Through study completion, up to 49 days (including screening period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start27 Apr 2023
- Primary completion11 Jul 2023
- Study completion11 Jul 2023
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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Stenkrona, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818514
- Sponsor's protocol ID
- D9690C00003
- Status last verified
- Jul 2023
- First submitted
- 15 Mar 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0 Open Label Positron Emission Tomography Study to Assess the Biodistribution and Binding Characteristics of [11C]AZ14132516 Following Administration to Healthy Participants
- ClinicalTrials.gov ID
- NCT05818514
- Acronym / sponsor ID
- D9690C00003
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 19 Apr 2023 (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 the regional distribution and binding of [11C]AZ14132516 to CCR9 in the abdomen using PET-CT examination in healthy participants.
Study details include:
The study duration will be up to 60 days.
The IV radioligand [11C]AZ14132516 will be administered at PET-CT examination: Visit 2 for the pilot panel; Visit 2 and 3 in the main panel.
There will be 2 study visits for the pilot panel and 3 study visits for the main panel.
Detailed description
This is a Phase 0, first in human (FIH) open label radioligand development study in healthy male and female participants. This radioligand development study will consist of two sequential panels:
Pilot panel (n = up to 3) Main panel (n = up to 6)
The purpose of the pilot panel is to perform initial PET-CT examinations using radioligand [11C]AZ14132516 and to optimise the imaging protocol. Up to 3 participants are planned to be included in this panel. Participants will attend the PET unit for a single visit and will be administered a single intravenous microdose of [11C]AZ14132516 (≤ 10μg regardless of body weight, approximately 400 MBq/70kg radioactivity) followed by a single PET-CT examination.
The purpose of the main panel is to assess [11C]AZ14132516 kinetics, binding characteristics, develop the quantitative analysis protocol and assess reproducibility of the analysis. Six participants are planned to be included in this panel. Participants will attend the PET unit for a baseline visit with administration of a single intravenous microdose of [11C]AZ14132516 followed by a PET-CT examination. Participants will return for a repeat visit 10 to14 days later where a second intravenous microdose of [11C]AZ14132516 will be administered followed by a second PET-CT examination.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [11C]AZ14132516 | Experimental | Drug: [11C]AZ14132516Pilot panel: up to 3 participants to complete 1 PET examination each during the course of the study Main panel: up to 6 participants to complete 2 PET examinations each during the course of the study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Informed Consent
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
- Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures.
- Participants ≥ 20 to 65 years of age inclusive, at the time of signing the ICF.
- Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory parameters and ECG performed before first administration of investigational product.
Key exclusion criteria (27 listed)
- Current significant major or unstable respiratory disease, heart disease, cerebrovascular disease, hematological disease, hepatic disease, renal disease, gastrointestinal disease, or other major diseases.
- Participants with unstable hypertension (as judged by the Investigator) or symptomatic hypotension, history of pre-syncope or syncope due to orthostatic hypotension and/or induced by change of posture (orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg).
- Significant abnormalities on the clinical examination, including neurological and physical examination, vital signs, ECG and clinical.
- Chemistry, hematology, or urine analysis results that may interfere with the study or present a safety risk to the patient.
- Abnormal vital signs, after 10 minutes of supine rest as judged by the PET centre physician. As a guide, any readings outside the following should be considered in the evaluation:
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]AZ14132516Also: No other namesInjection of radioligand for PET examinations | Drug | [11C]AZ14132516 |
Primary outcome
SUV and SUVR in abdominal regions of interest
Time frame: Immediately following administration of radioligand
Standardized uptake value (SUV) is the radioactivity concentration in given region of interest normalized for injected radioactivity and body weight. Standardised uptake value ratio (SUVR) is the ratio of SUV in a given region of interest to a reference region without significant radioligand uptake
2 secondary outcomes
Absolute percentage differences of SUV and SUVR, and intraclass correlation coefficients, in regions of interest between two test-retest PET examinations
Time frame: 10-14 days following initial administration of radioligand
Number of participants with safety findings, AEs
Time frame: Through study completion, up to 49 days (including screening period)
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 14 Jul 2023.
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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.
Per Stenkrona 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 Early Phase 1 study testing [11C]AZ14132516 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 15 inclusion and 27 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 14 Jul 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
SUV and SUVR in abdominal regions of interest (time frame: Immediately following administration of radioligand). 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 14 Jul 2023.