HealthyPhase 1NCT00892944
An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516
A Phase 1 study testing AZD2516 in people with Healthy, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain. This will then help to make accurate predictions of efficacy and dosing in the future development programme. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD2516
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2009to Oct 2009
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal MRI scan
- Healthy male or non-fertile females
- Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg
Who cannot join
- History of disease or condition that may interfere with the objectives of the study
- History of previous or ongoing psychiatric disease/condition
- Concomitant medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2516 After Oral Administration to Healthy Subjects
The purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain. This will then help to make accurate predictions of efficacy and dosing in the future development programme.
- Conditions
- Healthy
- Being tested
- AZD2516
- Keywords
- Positron Emission Tomography, Phase 1, Healthy volunteers, AZD2516
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2516Drug
Fractionated single oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD2516 Receives: Drug: AZD2516 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positron emission tomography to determine if AZD2516 can displace the radioligand [11C]AZ12713580 and describe relationship between AZD2516 exposure and mGluR5 receptor occupancy
Measured: 1 Month: Baseline and 3 PET examinations
Secondary outcomes (2)
Safety and tolerability of AZD2516 by adverse events, vitals signs, ECG, body temperature and laboratory variables
Measured: Assessed at each visit from baseline to follow-up visit
To investigate the Pharmacokinetics of AZD2516
Measured: 1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startApr 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ingemar Bylesjo, MD, PhD, Principal investigator, AstraZeneca Clinical Pharmacology Unit, Stockholm, SwedenMichael O'Malley, Study director, AstraZeneca R&D, Södertälje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892944
- Sponsor's protocol ID
- D2080C00009
- Status last verified
- Oct 2009
- First submitted
- 28 Apr 2009
- Last updated
- 28 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2516 After Oral Administration to Healthy Subjects
- ClinicalTrials.gov ID
- NCT00892944
- Acronym / sponsor ID
- D2080C00009
- Conditions
- Healthy
- Keywords
- Positron Emission Tomography, Phase 1, Healthy volunteers, AZD2516
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Study completion
- Oct 2009 (actual)
- First posted
- 5 May 2009 (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 determine if AZD2516 binds to mGluR5 receptors in the brain. This will then help to make accurate predictions of efficacy and dosing in the future development programme.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD2516AZD2516 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal MRI scan
- Healthy male or non-fertile females
- Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg
Key exclusion criteria (3 listed)
- History of disease or condition that may interfere with the objectives of the study
- History of previous or ongoing psychiatric disease/condition
- Concomitant medication
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 |
|---|---|---|
| AZD2516Fractionated single oral dose | Drug | 1 |
Primary outcome
Positron emission tomography to determine if AZD2516 can displace the radioligand [11C]AZ12713580 and describe relationship between AZD2516 exposure and mGluR5 receptor occupancy
Time frame: 1 Month: Baseline and 3 PET examinations
2 secondary outcomes
Safety and tolerability of AZD2516 by adverse events, vitals signs, ECG, body temperature and laboratory variables
Time frame: Assessed at each visit from baseline to follow-up visit
To investigate the Pharmacokinetics of AZD2516
Time frame: 1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose
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 Oct 2009.
Related trials for Healthy
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
Recruiting
Effects of a Hemp Seed-based Product on Appetite and Health Parameters
Healthy
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 recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
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.
Ingemar Bylesjo, MD, PhD principal investigator
AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Michael O'Malley study director
AstraZeneca R&D, Södertälje, Sweden
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 AZD2516 in people with Healthy, 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 3 inclusion and 3 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 Oct 2009. 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?
Positron emission tomography to determine if AZD2516 can displace the radioligand [11C]AZ12713580 and describe relationship between AZD2516 exposure and mGluR5 receptor occupancy (time frame: 1 Month: Baseline and 3 PET examinations). 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 28 Oct 2009.