Brain Distribution of [11C]AZ12807110 and AZD5213Phase 1NCT01194986
Evaluation of Histamine H3 Receptor Radioligand [11C]AZ12807110 and Histamine H3 Receptor Occupancy of AZD5213 After Oral Administration
A Phase 1 study testing [11C]AZ12807110 and AZD5213 in people with Brain Distribution of [11C]AZ12807110 and AZD5213, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate features of radioligand [11C]AZ12807110 and how much AZD5213 displaces radioligand from histamine receptors when given together. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Brain Distribution of [11C]AZ12807110 and AZD5213
- What is being tested?
- [11C]AZ12807110 and AZD5213
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2010to Jun 2011
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female volunteers between 20 to 45 years with suitable veins for cannulation or repeated venipuncture (pilot panel)
- Female must be of non-child bearing potential (pilot panel)
- BMI between 18 to 30 30 kg/m2
- Normal MRI scan
- Provision of signed, written and dated informed consent
Who cannot join
- History of any clinically significant disease or disorder
- History or presence of gastrointestinal, hepatic or renal disease
- Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
- History of severe allergy or hypersensitivity or ongoing allergy or hypersensitivity
- Healthy volunteer suffers from claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Positron Emission Tomography Study to Evaluate Use of Histamine H3 Receptor Radioligand [11C]AZ12807110 and to Determine Histamine H3 Receptor Occupancy of AZD5213 After Oral Administration to Healthy Volunteers
The purpose of this study is to investigate features of radioligand [11C]AZ12807110 and how much AZD5213 displaces radioligand from histamine receptors when given together.
- Being tested
- [11C]AZ12807110, AZD5213
- Keywords
- Receptor binding, Histamine H3 receptor, binding, radioligand
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]AZ12807110Other
Radioligand
AZD5213Drug
| Study group | Role | What they receive |
|---|---|---|
| Pilot panel | Experimental | [11C]AZ12807110 distribution and kinetics Receives: Other: [11C]AZ12807110 |
| Main panel | Experimental | Histamine receptor occupancy reached by AZD5213 Receives: Other: [11C]AZ12807110; Drug: AZD5213 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution volume (VT)
Measured: Venous blood samples for determination of concentrations of AZD5213 in plasma will be taken on many occasions from pre-dose until 48 h post-dose. Single PET measurement will take maximum 2 hours.
Estimation of the plasma concentration resulting in 50% receptor occupancy (Ki, pl).
Each healthy volunteer in the main panel will complete 3 PET measurements using radioligand; one at baseline and 2 after treatment with AZD5213.
Measured: Venous blood samples for determination of concentrations of AZD5213 in plasma will be taken on many occasions from pre-dose until 48 h post-dose.
Secondary outcomes (2)
Adverse events
Measured: Collected from Day 1 to follow-up
Vital signs (body temperature, BP and pulse)
Measured: Measured at screening, study days -1 to day 3 and at follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Distribution of [11C]AZ12807110 and AZD5213Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Björn Paulsson, MD, Study director, AstraZenecaWolfgang Kühn, MD, Principal investigator, Quintiles AB, Uppsala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194986
- Sponsor's protocol ID
- D3030C00003
- Other IDs
- 2009-010702-11, 2009
- Status last verified
- Jan 2015
- First submitted
- 2 Sep 2010
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jucaite A, Takano A, Bostrom E, Jostell KG, Stenkrona P, Halldin C, Segerdahl M, Nyberg S. AZD5213: a novel histamine H3 receptor antagonist permitting high daytime and low nocturnal H3 receptor occupancy, a PET study in human subjects. Int J Neuropsychopharmacol. 2013 Jul;16(6):1231-9. doi: 10.1017/S1461145712001411. Epub 2012 Dec 10.
PubMed 23217964
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Positron Emission Tomography Study to Evaluate Use of Histamine H3 Receptor Radioligand [11C]AZ12807110 and to Determine Histamine H3 Receptor Occupancy of AZD5213 After Oral Administration to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01194986
- Acronym / sponsor ID
- D3030C00003
- Keywords
- Receptor binding, Histamine H3 receptor, binding, radioligand
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Sep 2010 (estimated)
- 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 investigate features of radioligand [11C]AZ12807110 and how much AZD5213 displaces radioligand from histamine receptors when given together.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot panel | Experimental | Other: [11C]AZ12807110[11C]AZ12807110 distribution and kinetics |
| Main panel | Experimental | Other: [11C]AZ12807110, Drug: AZD5213Histamine receptor occupancy reached by AZD5213 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and/or female volunteers between 20 to 45 years with suitable veins for cannulation or repeated venipuncture (pilot panel)
- Female must be of non-child bearing potential (pilot panel)
- BMI between 18 to 30 30 kg/m2
- Normal MRI scan
- Provision of signed, written and dated informed consent
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder
- History or presence of gastrointestinal, hepatic or renal disease
- Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
- History of severe allergy or hypersensitivity or ongoing allergy or hypersensitivity
- Healthy volunteer suffers from claustrophobia
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]AZ12807110Radioligand | Other | Main panel, Pilot panel |
| AZD5213 | Drug | Main panel |
Primary outcome
Distribution volume (VT)
Time frame: Venous blood samples for determination of concentrations of AZD5213 in plasma will be taken on many occasions from pre-dose until 48 h post-dose. Single PET measurement will take maximum 2 hours.
Estimation of the plasma concentration resulting in 50% receptor occupancy (Ki, pl).
Time frame: Venous blood samples for determination of concentrations of AZD5213 in plasma will be taken on many occasions from pre-dose until 48 h post-dose.
Each healthy volunteer in the main panel will complete 3 PET measurements using radioligand; one at baseline and 2 after treatment with AZD5213.
2 secondary outcomes
Adverse events
Time frame: Collected from Day 1 to follow-up
Vital signs (body temperature, BP and pulse)
Time frame: Measured at screening, study days -1 to day 3 and at follow-up
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 28 Jan 2015.
- Derived from this study: PubMed 23217964Jucaite A, Takano A, Bostrom E, Jostell KG, Stenkrona P, Halldin C, Segerdahl M, Nyberg S. AZD5213: a novel histamine H3 receptor antagonist permitting high daytime and low nocturnal H3 receptor occupancy, a PET study in human subjects. Int J Neuropsychopharmacol. 2013 Jul;16(6):1231-9. doi: 10.1017/S1461145712001411. Epub 2012 Dec 10.
- D3030C00003 Clinical Study Report SynopsisLink provided by the sponsor.
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.
Björn Paulsson, MD study director
AstraZeneca
Wolfgang Kühn, MD principal investigator
Quintiles AB, Uppsala
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]AZ12807110 and AZD5213 in people with Brain Distribution of [11C]AZ12807110 and AZD5213, 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 5 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 28 Jan 2015. 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?
Distribution volume (VT) (time frame: Venous blood samples for determination of concentrations of AZD5213 in plasma will be taken on many occasions from pre-dose until 48 h post-dose. Single PET measurement will take maximum 2 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01194986, which also lists 1 linked publication.
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 28 Jan 2015.