Chronic PainPhase 1NCT00930306
AZD2066 Cocktail Study
A Phase 1 study testing AZD2066, Caffeine and Tolbutamide in people with Chronic Pain, run by AstraZeneca at 2 sites in United Kingdom.
Trial summary
The aims of this study are to examine the effect of repeated doses of AZD2066 and of caffeine, bupropion, tolbutamide, omeprazole, metoprolol and midazolam on the blood concentrations of each other Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- AZD2066, Caffeine and Tolbutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2009to Sep 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of informed consent prior to any study-specific procedures
- Healthy volunteers with BMI between 18 and 30 kg/m2
- Medical and surgical history and physical examination without any clinically significant findings
- Non smokers or past smokers who have stopped smoking within the last 6 months.
Who cannot join
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, personality disorder or other significant psychiatric disorders or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
- Clinically significant illness as judged by the Investigator, within four weeks before the first administration of investigational product.
- Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase I, Open Label, Multi Centre Study in Healthy Volunteers to Estimate the Effect of Multiple Doses of AZD2066 on the Activity of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 by Administering a Cocktail of Caffeine, Bupropion, Tolbutamide, Omeprazole, Metoprolol and Midazolam
The aims of this study are to examine the effect of repeated doses of AZD2066 and of caffeine, bupropion, tolbutamide, omeprazole, metoprolol and midazolam on the blood concentrations of each other
- Conditions
- Chronic Pain
- Being tested
- AZD2066, Caffeine, Tolbutamide, Omeprazole Tablet, 20 mg, Midazolam Tablet, 7.5 mg
- Keywords
- Chronic Pain, AZD2066
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2066Drug
12 doses, Given as capsule, 2 mg \& 8 mg
CaffeineDrug
Also called Pharmapac/ProPlus®
2 doses, Given as Tablet, 2x50 mg
TolbutamideDrug
Also called Actavis /generic
2 doses, Given as Tablet, half of 500 mg
Omeprazole Tablet, 20 mgDrug
Also called AstraZeneca/Losec® MUPS®
2 doses, Given as Tablet, 20 mg
Midazolam Tablet, 7.5 mgDrug
Also called Roche/generic
2 doses, Given as Tablet, 7.5 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 12 AZD2066 Capsule, 2 mg \& 8 mg 2 Caffeine Tablet, 2 x 50 mg 2 Tolbutamide Tablet, half of 500 mg 2 Omeprazole Tablet, 20 mg 2 Midazolam Tablet, 7.5 mg 2 Metoprolol Tablet, 100 mg 2 Bupropion Tablet, 150 mg Receives: Drug: AZD2066; Drug: Caffeine; Drug: Tolbutamide; Drug: Omeprazole Tablet, 20 mg; Drug: Midazolam Tablet, 7.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK variables
Measured: Frequent sampling occasions during
Secondary outcomes (1)
Safety variables (adverse events, blood pressure, pulse, safety lab)
Measured: Frequent sampling occasions during
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biljana Lilja, Study director, AstraZeneca R&D, Södertälje, SwedenSimon Constable, Principal investigator, ICON Development Solutions, Manchester, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930306
- Sponsor's protocol ID
- D0475C00011
- Status last verified
- Oct 2009
- First submitted
- 29 Jun 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Multi Centre Study in Healthy Volunteers to Estimate the Effect of Multiple Doses of AZD2066 on the Activity of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 by Administering a Cocktail of Caffeine, Bupropion, Tolbutamide, Omeprazole, Metoprolol and Midazolam
- ClinicalTrials.gov ID
- NCT00930306
- Acronym / sponsor ID
- D0475C00011
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, AZD2066
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Study completion
- Sep 2009 (actual)
- First posted
- 30 Jun 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 aims of this study are to examine the effect of repeated doses of AZD2066 and of caffeine, bupropion, tolbutamide, omeprazole, metoprolol and midazolam on the blood concentrations of each other
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD2066, Drug: Caffeine, Drug: Tolbutamide, Drug: Omeprazole Tablet, 20 mg, Drug: Midazolam Tablet, 7.5 mg12 AZD2066 Capsule, 2 mg \& 8 mg 2 Caffeine Tablet, 2 x 50 mg 2 Tolbutamide Tablet, half of 500 mg 2 Omeprazole Tablet, 20 mg 2 Midazolam Tablet, 7.5 mg 2 Metoprolol Tablet, 100 mg 2 Bupropion Tablet, 150 mg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provision of informed consent prior to any study-specific procedures
- Healthy volunteers with BMI between 18 and 30 kg/m2
- Medical and surgical history and physical examination without any clinically significant findings
- Non smokers or past smokers who have stopped smoking within the last 6 months.
Key exclusion criteria (3 listed)
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, personality disorder or other significant psychiatric disorders or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
- Clinically significant illness as judged by the Investigator, within four weeks before the first administration of investigational product.
- Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding
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 |
|---|---|---|
| AZD206612 doses, Given as capsule, 2 mg \& 8 mg | Drug | 1 |
| CaffeineAlso: Pharmapac/ProPlus®2 doses, Given as Tablet, 2x50 mg | Drug | 1 |
| TolbutamideAlso: Actavis /generic2 doses, Given as Tablet, half of 500 mg | Drug | 1 |
| Omeprazole Tablet, 20 mgAlso: AstraZeneca/Losec® MUPS®2 doses, Given as Tablet, 20 mg | Drug | 1 |
| Midazolam Tablet, 7.5 mgAlso: Roche/generic2 doses, Given as Tablet, 7.5 mg | Drug | 1 |
Primary outcome
PK variables
Time frame: Frequent sampling occasions during
1 secondary outcome
Safety variables (adverse events, blood pressure, pulse, safety lab)
Time frame: Frequent sampling occasions during
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 27 Oct 2009.
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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.
Biljana Lilja study director
AstraZeneca R&D, Södertälje, Sweden
Simon Constable principal investigator
ICON Development Solutions, Manchester, UK
2 sites 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, Caffeine and Tolbutamide in people with Chronic Pain, run by AstraZeneca at 2 sites in United Kingdom.
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 4 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 27 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 2 sites in United Kingdom. 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?
PK variables (time frame: Frequent sampling occasions during). 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 27 Oct 2009.