HealthyPhase 1NCT00690404
AZD 2066 Single Dose Formulation and Food Effect Study in Healthy Volunteers
A Phase 1 study testing AZD2066 in people with Healthy, run by AstraZeneca.
Trial summary
A open label two way crossover formulation and food effect study in healthy volunteers to assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an oral solution 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?
- AZD2066
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical normal physical findings, including BP, pulse rate >45 bpm, ECG and laboratory assessments
- Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg
Who cannot join
- History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
- History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.
About this study
Official title: A Phase 1, Single-center, Randomized, Open-label, Two-way Crossover, Formulation and Food Effect Study in Healthy Volunteers, to Assess the Pharmacokinetics of AZD 2066 After Single Doses of a New Oral Solid Formulation and an Oral Solution
A open label two way crossover formulation and food effect study in healthy volunteers to assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an oral solution
- Conditions
- Healthy
- Being tested
- AZD2066
- Keywords
- formulation, pharmacokinetic, crossover formulation, food effect, oral solution, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2066Drug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD2066 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AZ2066 pharmacokinetics
Measured: several samples within 72 hrs
Secondary outcomes (1)
Effect of food on AZD2066 pharmacokinetics
Measured: several samples over 72 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 2008
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eleanor Lisbon, MD, MPH, Principal investigator, Quintiles, Inc. Overland Park, Kansas, USAHeather Wray, MB, ChB, FFPM, Study chair, AstraZeneca Charnwood EnglandIvan Eggens, MD, Study chair, AstraZeneca , Södertälje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690404
- Sponsor's protocol ID
- D0475C00005
- Status last verified
- Dec 2010
- First submitted
- 2 Jun 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
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 1, Single-center, Randomized, Open-label, Two-way Crossover, Formulation and Food Effect Study in Healthy Volunteers, to Assess the Pharmacokinetics of AZD 2066 After Single Doses of a New Oral Solid Formulation and an Oral Solution
- ClinicalTrials.gov ID
- NCT00690404
- Acronym / sponsor ID
- D0475C00005
- Conditions
- Healthy
- Keywords
- formulation, pharmacokinetic, crossover formulation, food effect, oral solution, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 4 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.
A open label two way crossover formulation and food effect study in healthy volunteers to assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an oral solution
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD2066 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical normal physical findings, including BP, pulse rate >45 bpm, ECG and laboratory assessments
- Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg
Key exclusion criteria (2 listed)
- History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
- History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.
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 |
|---|---|---|
| AZD2066single oral dose | Drug | 1 |
Primary outcome
AZ2066 pharmacokinetics
Time frame: several samples within 72 hrs
1 secondary outcome
Effect of food on AZD2066 pharmacokinetics
Time frame: several samples over 72 hrs
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.
Eleanor Lisbon, MD, MPH principal investigator
Quintiles, Inc. Overland Park, Kansas, USA
Heather Wray, MB, ChB, FFPM study chair
AstraZeneca Charnwood England
Ivan Eggens, MD study chair
AstraZeneca , Södertälje, Sweden
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD2066 in people with Healthy, run by AstraZeneca.
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 2 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.
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?
AZ2066 pharmacokinetics (time frame: several samples within 72 hrs). 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.