MetabolismPhase 1CocktailNCT00692510
Drug Interaction Study Between AZD3480 and Cytochrome P450
A Phase 1 study testing AZD3480 and Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin) in people with Metabolism and Alzheimer's Disease, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 activity. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism, Alzheimer's Disease
- What is being tested?
- AZD3480 and Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2007to Sep 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed written informed consent
- Clinically normal physical findings and laboratory values
Who cannot join
- Clinically significant illness or clinically relevant trauma within three weeks before the first dose
- History of clinically significant disease
- Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double Blind, Randomized, Two-Way Cross Over, Single- Centre Study in Healthy CYP2D6 Extensive Metabolizers and Poor Metabolizers to Investigate the Potential of AZD3480 to Inhibit Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 Activity
The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 activity.
- Conditions
- Metabolism, Alzheimer's Disease
- Being tested
- AZD3480, Placebo, Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)
- Keywords
- AZD3480, Cocktail, caffeine, bupropion, omeprazole, midazolam, rosiglitazone, metabolism, Drug Drug Interaction
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3480Drug
Capsule, oral, dose once daily, 7 days
PlaceboDrug
Capsule, oral, dose once daily, 7 days
Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)Drug
Cocktail mix which contains the following:
CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin)
single dose of mix
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD3480 + cocktail Receives: Drug: AZD3480; Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin) |
| 2 | Placebo comparator | Placebo + cocktail Receives: Drug: Placebo; Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK variables
Measured: Frequent sampling occasions during the treatment periods
Secondary outcomes (1)
Safety variables (adverse events, blood pressure, pulse, safety lab)
Measured: During the whole treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hans-Göran Hårdemark, MD, Study director, AstraZeneca R&D, Södertälje, SwedenCyril Clarke, MD, Principal investigator, ICON Development Solutions Manchester, Manchester Science Park, Manchester, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692510
- Sponsor's protocol ID
- D3690C00016
- Other IDs
- EudraCt nr 2007-002456-10
- Acronym
- Cocktail
- Status last verified
- Nov 2008
- First submitted
- 29 May 2008
- Last updated
- 26 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double Blind, Randomized, Two-Way Cross Over, Single- Centre Study in Healthy CYP2D6 Extensive Metabolizers and Poor Metabolizers to Investigate the Potential of AZD3480 to Inhibit Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 Activity
- ClinicalTrials.gov ID
- NCT00692510
- Acronym / sponsor ID
- Cocktail / D3690C00016
- Conditions
- Metabolism, Alzheimer's Disease
- Keywords
- AZD3480, Cocktail, caffeine, bupropion, omeprazole, midazolam, rosiglitazone, metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Jun 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 the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD3480, Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)AZD3480 + cocktail |
| 2 | Placebo comparator | Drug: Placebo, Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)Placebo + cocktail |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provision of signed written informed consent
- Clinically normal physical findings and laboratory values
Key exclusion criteria (3 listed)
- Clinically significant illness or clinically relevant trauma within three weeks before the first dose
- History of clinically significant disease
- Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
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 |
|---|---|---|
| AZD3480Capsule, oral, dose once daily, 7 days | Drug | 1 |
| PlaceboCapsule, oral, dose once daily, 7 days | Drug | 2 |
| Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)Cocktail mix which contains the following: CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin) single dose of mix | Drug | 1, 2 |
Primary outcome
PK variables
Time frame: Frequent sampling occasions during the treatment periods
1 secondary outcome
Safety variables (adverse events, blood pressure, pulse, safety lab)
Time frame: During the whole treatment period
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 Nov 2008.
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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.
Hans-Göran Hårdemark, MD study director
AstraZeneca R&D, Södertälje, Sweden
Cyril Clarke, MD principal investigator
ICON Development Solutions Manchester, Manchester Science Park, Manchester, UK
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 AZD3480 and Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin) in people with Metabolism and Alzheimer's Disease, 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 26 Nov 2008. 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?
PK variables (time frame: Frequent sampling occasions during the treatment periods). 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 Nov 2008.