Healthy Volunteer Male SubjectsPhase 1NCT03215381
AZD1390 Administration of a Microdose [11C]AZD1390 to Healthy Volunteers
A Phase 1 study testing [11C]AZD1390 in people with Healthy Volunteer Male Subjects, run by AstraZeneca at 1 site in Sweden.
Trial summary
This is an open-label, single centre exploratory study to analyse brain exposure of AZD1390 in healthy volunteer males. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Male Subjects
- What is being tested?
- [11C]AZD1390
- 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
- 10 Oct 2017to 19 Feb 2018
- 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 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy Male subjects, aged 20 to 65 years (inclusive).
- Subject should be healthy as determined by medical history, physical examination, laboratory parameters, ECG and brain MRI performed before administration of the investigational product.
- Subject should have a body mass index (BMI) between 18.0 and 30.0 kg/m2 and must weigh at least 50.0 kg and no more than 100.0 kg.
- Male subjects must be willing to adhere to true sexual abstinence or use condoms and spermicide (refer to Section 4.3); and refrain from donating sperm during the study and for 3 months plus 5 half-lives after the last administered radiolabelled infusion of [11C]AZD1390.
- Subject should be willing and able to participate in all scheduled evaluations, abide by study restrictions, and complete all required tests and procedures.
Who cannot join
- Known or suspected neurological or behavioural disorders or symptoms that may interfere with the conduct or interpretation of the study, dementia (significant concomitant neurological disease are included under this category).
- Current significant major or unstable respiratory, heart, cerebrovascular, haematological, hepatic, renal, gastrointestinal diseases, or other major disease.
- Suffers from claustrophobia that limits the ability to undergo the scanning procedure.
- Subject has implanted metal devices or implants (MRI contraindications).
- Subject has received any concomitant medication or herbal medicine within 2 weeks prior to study drug administration.
- Subject has a negative Allen test in both hands at screening, unless brachial artery is used for arterial cannulation.
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- Use of any anticoagulant within 30 days prior to study drug administration.
- Subject has previously participated in a PET imaging study.
- Central nervous system infarct, infection or focal lesions of clinical significance on brain MRI scan or abnormalities observed on the brain MRI that would interfere with image analysis
- As judged by the investigator, subject with unstable hypertension 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).
- Presence of significant abnormalities on physical and neurological clinical examinations, vital signs, ECG and clinical chemistry, haematology, or urine analysis results at screening that may interfere with the study or present a safety risk to the study subject.
- History or positive results for a systemic infection (e.g. hepatitis B virus, hepatitis C virus, HIV, tuberculosis), including previous or on-going infectious or autoimmune disease at screening.
- History of alcohol or drug abuse or dependence (except nicotine) within 1 year prior to screening and/or urine drug screen positive for drug abuse.
- Prolonged QTcF >450 ms or family history of long QT syndrome.
- History of severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to [11C]AZD1390.
- Judgment by the investigator of any other reason that would prohibit the inclusion of the subject in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Positron-Emission Tomography (PET) Study to Determine Brain Exposure of AZD1390 After Intravenous Administration of a Microdose [11C]AZD1390 to Healthy Volunteers
This is an open-label, single centre exploratory study to analyse brain exposure of AZD1390 in healthy volunteer males.
Read the detailed description
Up to 12 healthy male volunteers, 20 to 65 years of age will participate in the study. The study population chosen is sufficient to examine variability in pharmacokinetic and imaging measurements. All male volunteer subjects will have a baseline brain magnetic resonance imaging (MRI) for eligibility and anatomical delineation of brain regions to be applied in positron emission tomography (PET) image analysis. An arterial line will be inserted on day the healthy volunteer arrives for the administration of study drug and PET imaging (Day 1). The arterial line will be placed in the opposite arm than the one being used to administer the single intravenous microdose of [11C]AZD1390. Blood samples will be collected after the administration of microdose [11C]AZD1390 bolus injection and during the PET imaging procedure. The arterial line will be removed at the conclusion of the PET imaging study after the last blood sample has been collected. Standard institutional procedures will be followed for arterial line removal. The study will conclude with a telephone follow-up call within 7 business days after the PET measurement.
- Conditions
- Healthy Volunteer Male Subjects
- Being tested
- [11C]AZD1390
- Keywords
- Healthy Volunteer Male Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]AZD1390Drug
Also called Radiolabeled AZD1390
[11C]AZD1390
| Study group | Role | What they receive |
|---|---|---|
| [11C]AZD1390 Microdose | Other | [11C]AZD1390 single dose not exceeding 10 ug by IV bolus Receives: Drug: [11C]AZD1390 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain distribution of AZD1390
To assess if 11C AZD1390 crosses the blood brain barrier in healthy volunteers
Measured: up to 2 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start10 Oct 2017
- Primary completion19 Feb 2018
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer Male SubjectsStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet, Quintiles IMS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215381
- Sponsor's protocol ID
- D6940C00001
- Status last verified
- Feb 2018
- First submitted
- 29 Jun 2017
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Positron-Emission Tomography (PET) Study to Determine Brain Exposure of AZD1390 After Intravenous Administration of a Microdose [11C]AZD1390 to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03215381
- Acronym / sponsor ID
- D6940C00001
- Conditions
- Healthy Volunteer Male Subjects
- Keywords
- Healthy Volunteer Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Karolinska Institutet, Quintiles IMS
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 12 Jul 2017 (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.
This is an open-label, single centre exploratory study to analyse brain exposure of AZD1390 in healthy volunteer males.
Detailed description
Up to 12 healthy male volunteers, 20 to 65 years of age will participate in the study. The study population chosen is sufficient to examine variability in pharmacokinetic and imaging measurements. All male volunteer subjects will have a baseline brain magnetic resonance imaging (MRI) for eligibility and anatomical delineation of brain regions to be applied in positron emission tomography (PET) image analysis. An arterial line will be inserted on day the healthy volunteer arrives for the administration of study drug and PET imaging (Day 1). The arterial line will be placed in the opposite arm than the one being used to administer the single intravenous microdose of [11C]AZD1390. Blood samples will be collected after the administration of microdose [11C]AZD1390 bolus injection and during the PET imaging procedure. The arterial line will be removed at the conclusion of the PET imaging study after the last blood sample has been collected. Standard institutional procedures will be followed for arterial line removal. The study will conclude with a telephone follow-up call within 7 business days after the PET measurement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [11C]AZD1390 Microdose | Other | Drug: [11C]AZD1390[11C]AZD1390 single dose not exceeding 10 ug by IV bolus |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy Male subjects, aged 20 to 65 years (inclusive).
- Subject should be healthy as determined by medical history, physical examination, laboratory parameters, ECG and brain MRI performed before administration of the investigational product.
- Subject should have a body mass index (BMI) between 18.0 and 30.0 kg/m2 and must weigh at least 50.0 kg and no more than 100.0 kg.
- Male subjects must be willing to adhere to true sexual abstinence or use condoms and spermicide (refer to Section 4.3); and refrain from donating sperm during the study and for 3 months plus 5 half-lives after the last administered radiolabelled infusion of [11C]AZD1390.
Key exclusion criteria (16 listed)
- Known or suspected neurological or behavioural disorders or symptoms that may interfere with the conduct or interpretation of the study, dementia (significant concomitant neurological disease are included under this category).
- Current significant major or unstable respiratory, heart, cerebrovascular, haematological, hepatic, renal, gastrointestinal diseases, or other major disease.
- Suffers from claustrophobia that limits the ability to undergo the scanning procedure.
- Subject has implanted metal devices or implants (MRI contraindications).
- Subject has received any concomitant medication or herbal medicine within 2 weeks prior to study drug administration.
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]AZD1390Also: Radiolabeled AZD1390[11C]AZD1390 | Drug | [11C]AZD1390 Microdose |
Primary outcome
Brain distribution of AZD1390
Time frame: up to 2 hours post dose
To assess if 11C AZD1390 crosses the blood brain barrier in healthy volunteers
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 26 Feb 2018.
- Individual participant dataSharing planned: No
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Healthy Subjects
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.
The record lists no contact. Use the official record to reach the sponsor.
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]AZD1390 in people with Healthy Volunteer Male Subjects, 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 6 inclusion and 16 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 26 Feb 2018. 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?
Brain distribution of AZD1390 (time frame: up to 2 hours post dose). 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 26 Feb 2018.