Healthy Volunteer StudyPhase 1NCT00866385
AZD8566 Food Effect/Microtracer Study
A Phase 1 study testing AZD8566 and AZD8566 IV carbon labelled in people with Healthy Volunteer Study, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
A study designed to look at how the drug AZD8566 is taken up by the body when given with or without food. In some subjects a comparison will be made with a very small labelled microdose given into a vein. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- AZD8566 and AZD8566 IV carbon labelled
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2009to Apr 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written informed consent
- Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
- Females who are permanently or surgically sterile or post-menopausal and males
Who cannot join
- History of any convulsions or seizures
- History of infection or risk of infection due to recent surgery or trauma
- History or presence of conditions know to interfere with the absorption, distribution, metabolism and excretion of the study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomised, Phase I, 2-Period Crossover Trial to Investigate the Absolute Bioavailability and the Effect of Food on the Oral Bioavailability of AZD8566 in Healthy Volunteers
A study designed to look at how the drug AZD8566 is taken up by the body when given with or without food. In some subjects a comparison will be made with a very small labelled microdose given into a vein.
- Conditions
- Healthy Volunteer Study
- Being tested
- AZD8566, AZD8566 IV carbon labelled
- Keywords
- Healthy Volunteer, AZD8566, Food Effect, Microtracer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8566Drug
Single 6 mg oral solution dose
AZD8566 IV carbon labelledDrug
Single 10 mcg intravenous carbon-14 microtracer dose
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food
Measured: Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose
Secondary outcomes (3)
Safety and tolerability of AZD8566 in healthy volunteers in the fed and fasted state by assessment of vital signs, laboratory variables, ECGs and adverse events
Measured: Assessments taken during visit 1 and at defined timepoints pre and post dose during visits 2 and 3. Volunteers will be monitored throughout the study for adverse events.
Bioavailability of an oral solution formulation of AZD8566 in the fasted state compared with an intravenous carbon-14 microtracer dose
Measured: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
Intravenous pharmacokinetics
Measured: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies 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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jo Collier, Dr,MB, ChB, Principal investigator, Pharmaceutical Profiles, Mere Way, Ruddington Fields, Nottingham NG11 6JS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866385
- Sponsor's protocol ID
- D1320C00011
- Other IDs
- Pharmaceutical Profiles PL1168
- Status last verified
- Jun 2009
- First submitted
- 19 Mar 2009
- Last updated
- 9 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomised, Phase I, 2-Period Crossover Trial to Investigate the Absolute Bioavailability and the Effect of Food on the Oral Bioavailability of AZD8566 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00866385
- Acronym / sponsor ID
- D1320C00011
- Conditions
- Healthy Volunteer Study
- Keywords
- Healthy Volunteer, AZD8566, Food Effect, Microtracer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Mar 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.
A study designed to look at how the drug AZD8566 is taken up by the body when given with or without food. In some subjects a comparison will be made with a very small labelled microdose given into a vein.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of written informed consent
- Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
- Females who are permanently or surgically sterile or post-menopausal and males
Key exclusion criteria (3 listed)
- History of any convulsions or seizures
- History of infection or risk of infection due to recent surgery or trauma
- History or presence of conditions know to interfere with the absorption, distribution, metabolism and excretion of the 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 |
|---|---|---|
| AZD8566Single 6 mg oral solution dose | Drug | – |
| AZD8566 IV carbon labelledSingle 10 mcg intravenous carbon-14 microtracer dose | Drug | – |
Primary outcome
Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food
Time frame: Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose
3 secondary outcomes
Safety and tolerability of AZD8566 in healthy volunteers in the fed and fasted state by assessment of vital signs, laboratory variables, ECGs and adverse events
Time frame: Assessments taken during visit 1 and at defined timepoints pre and post dose during visits 2 and 3. Volunteers will be monitored throughout the study for adverse events.
Bioavailability of an oral solution formulation of AZD8566 in the fasted state compared with an intravenous carbon-14 microtracer dose
Time frame: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
Intravenous pharmacokinetics
Time frame: Samples taken during visit 2, at up to 40 defined timepoints pre and post 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 9 Jun 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.
Jo Collier, Dr,MB, ChB principal investigator
Pharmaceutical Profiles, Mere Way, Ruddington Fields, Nottingham NG11 6JS
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 AZD8566 and AZD8566 IV carbon labelled in people with Healthy Volunteer Study, run by AstraZeneca at 1 site 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 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 9 Jun 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 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?
Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food (time frame: Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose). 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 9 Jun 2009.