PainPhase 1NCT00684502
Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects
A Phase 1 study testing AZD2066 in people with Pain, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the safety and tolerability of AZD2066 using multiple escalating dose panels. There will be separate panels for young healthy volunteers and elderly healthy volunteers. Each panel will contain 10 volunteers who will randomly receive AZD2066 or placebo. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- AZD2066
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Nov 2008
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed informed consent
- Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.
Who cannot join
- History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
- Intake of medicine (except occasional paracetamol or nasal spray) within first 2 weeks before first administration of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects After Oral Multiple Ascending Doses
The purpose of this study is to investigate the safety and tolerability of AZD2066 using multiple escalating dose panels. There will be separate panels for young healthy volunteers and elderly healthy volunteers. Each panel will contain 10 volunteers who will randomly receive AZD2066 or placebo. One panel will be run at a time with a fixed dose given. After the completion of each panel, a Safety Review Committee will decide if the study can proceed to the next dose panel.
- Conditions
- Pain
- Being tested
- AZD2066, Placebo
- Keywords
- Safety, tolerability, AZD2066, Pain conditions
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2066Drug
Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel.
PlaceboDrug
Administered orally as a solution once per day on day 1, and then day 3 through to day 12.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral solution. Receives: Drug: AZD2066 |
| 2 | Placebo comparator | Oral solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables and ECG
Measured: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 15 and follow up visit 3
Secondary outcomes (3)
Safety and tolerability of AZD2066 by assessment of adverse events
Measured: Non serious adverse events will be collected from the start of Visit 2 until the end of the study. Serious adverse events will be collected from signing of consent until end of study.
Investigate PK profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 (and possible relevant metabolites).
Measured: PK sampling taken at defined timepoints during residential period and follow-up.
Investigate CNS effects of AZD2066
Measured: Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bo Fransson, MD, Principal investigator, AstraZeneca R&D SödertäljeMedical Science, CPU C2:84Karolinska University Hospital HuddingeSE-141 86 Stockholm, SwedenLars Stahle, MD, PhD, Study chair, AstraZeneca R&D Södertälje Medical Science S-151 85 Södertälje Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684502
- Sponsor's protocol ID
- D0475C00002
- Other IDs
- EudractCT 2007-005524-33
- Status last verified
- Dec 2008
- First submitted
- 22 May 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects After Oral Multiple Ascending Doses
- ClinicalTrials.gov ID
- NCT00684502
- Acronym / sponsor ID
- D0475C00002
- Conditions
- Pain
- Keywords
- Safety, tolerability, AZD2066, Pain conditions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 26 May 2008 (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 the safety and tolerability of AZD2066 using multiple escalating dose panels. There will be separate panels for young healthy volunteers and elderly healthy volunteers. Each panel will contain 10 volunteers who will randomly receive AZD2066 or placebo. One panel will be run at a time with a fixed dose given. After the completion of each panel, a Safety Review Committee will decide if the study can proceed to the next dose panel.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD2066Oral solution. |
| 2 | Placebo comparator | Drug: PlaceboOral solution |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Provision of signed informed consent
- Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.
Key exclusion criteria (3 listed)
- History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
- Intake of medicine (except occasional paracetamol or nasal spray) within first 2 weeks before first administration of study drug.
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 |
|---|---|---|
| AZD2066Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel. | Drug | 1 |
| PlaceboAdministered orally as a solution once per day on day 1, and then day 3 through to day 12. | Drug | 2 |
Primary outcome
Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables and ECG
Time frame: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 15 and follow up visit 3
3 secondary outcomes
Safety and tolerability of AZD2066 by assessment of adverse events
Time frame: Non serious adverse events will be collected from the start of Visit 2 until the end of the study. Serious adverse events will be collected from signing of consent until end of study.
Investigate PK profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 (and possible relevant metabolites).
Time frame: PK sampling taken at defined timepoints during residential period and follow-up.
Investigate CNS effects of AZD2066
Time frame: Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes.
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 10 Dec 2010.
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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.
Bo Fransson, MD principal investigator
AstraZeneca R&D SödertäljeMedical Science, CPU C2:84Karolinska University Hospital HuddingeSE-141 86 Stockholm, Sweden
Lars Stahle, MD, PhD study chair
AstraZeneca R&D Södertälje Medical Science S-151 85 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 AZD2066 in people with Pain, 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 2 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 10 Dec 2010. 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables and ECG (time frame: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 15 and follow up visit 3). 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 10 Dec 2010.