HealthyPhase 1NCT00908934
AZD9056 Relative Bioavailability Study
A Phase 1 study testing AZD9056 formulation Phase III 50 mg (T), AZD9056 formulation Phase IIb 50 mg (R) and AZD9056 formulation Phase III 200 mg (T) in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD9056 formulation Phase III 50 mg (T), AZD9056 formulation Phase IIb 50 mg (R) and AZD9056 formulation Phase III 200 mg (T)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to Jul 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 informed consent prior to any study-specific procedures
- Healthy Volunteers, Females should not be of childbearing potential
- BMI between 18 and 30 kg/m2
Who cannot join
- Clinically significant ECG abnormality suggestive of underlying cardiovascular disease
- A history or presence of GI, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism and excretion of drugs
- Known or suspected drug or alcohol abuse or positive DOA test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, 2 Cohort, 2 Period Crossover Study to Assess the Relative Bioavailability of the Phase III to the Phase IIb Formulation of AZD9056 in Healthy Male and Female Subjects
The aims of this study are to compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.
- Conditions
- Healthy
- Being tested
- AZD9056 formulation Phase III 50 mg (T), AZD9056 formulation Phase IIb 50 mg (R), AZD9056 formulation Phase III 200 mg (T), AZD9056 formulation Phase IIb 200mg (R)
- Keywords
- Relative Bioavailability, AZD9056
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9056 formulation Phase III 50 mg (T)Drug
Given as 50 mg tablet (T)
AZD9056 formulation Phase IIb 50 mg (R)Drug
Given as 50 mg tablet (R)
AZD9056 formulation Phase III 200 mg (T)Drug
Given as 400 mg (2 x 200 mg tablet (T))
AZD9056 formulation Phase IIb 200mg (R)Drug
Given as 400 mg (2 x 200 mg tablet (R))
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 50 or 400 mg AZD9056, Test formulation Receives: Drug: AZD9056 formulation Phase III 50 mg (T); Drug: AZD9056 formulation Phase III 200 mg (T) |
| 2 | Experimental | 50 or 400 mg AZD9056, Reference formulation Receives: Drug: AZD9056 formulation Phase IIb 50 mg (R); Drug: AZD9056 formulation Phase IIb 200mg (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of AZD9056 using PK variables Cmax and AUC
Measured: For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7
Secondary outcomes (2)
Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F)
Measured: For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7
Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)
Measured: Frequent sampling occasions throughout the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startMay 2009
- Study completionJul 2009
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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Layton, Study director, AstraZeneca R&D, Alderley Park, UKSimon Constable, Principal investigator, ICON Development Solutions, Manchester, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908934
- Sponsor's protocol ID
- D1520C00004
- Other IDs
- EudraCT Number: 2009-010554-35
- Status last verified
- Jul 2009
- First submitted
- 22 May 2009
- Last updated
- 23 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, 2 Cohort, 2 Period Crossover Study to Assess the Relative Bioavailability of the Phase III to the Phase IIb Formulation of AZD9056 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT00908934
- Acronym / sponsor ID
- D1520C00004
- Conditions
- Healthy
- Keywords
- Relative Bioavailability, AZD9056
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Study completion
- Jul 2009 (actual)
- First posted
- 27 May 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 compare the blood levels achieved with a new formulation of AZD9056 to an existing formulation of AZD9056 used in previous studies.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD9056 formulation Phase III 50 mg (T), Drug: AZD9056 formulation Phase III 200 mg (T)50 or 400 mg AZD9056, Test formulation |
| 2 | Experimental | Drug: AZD9056 formulation Phase IIb 50 mg (R), Drug: AZD9056 formulation Phase IIb 200mg (R)50 or 400 mg AZD9056, Reference formulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study-specific procedures
- Healthy Volunteers, Females should not be of childbearing potential
- BMI between 18 and 30 kg/m2
Key exclusion criteria (3 listed)
- Clinically significant ECG abnormality suggestive of underlying cardiovascular disease
- A history or presence of GI, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism and excretion of drugs
- Known or suspected drug or alcohol abuse or positive DOA test
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 |
|---|---|---|
| AZD9056 formulation Phase III 50 mg (T)Given as 50 mg tablet (T) | Drug | 1 |
| AZD9056 formulation Phase IIb 50 mg (R)Given as 50 mg tablet (R) | Drug | 2 |
| AZD9056 formulation Phase III 200 mg (T)Given as 400 mg (2 x 200 mg tablet (T)) | Drug | 1 |
| AZD9056 formulation Phase IIb 200mg (R)Given as 400 mg (2 x 200 mg tablet (R)) | Drug | 2 |
Primary outcome
Relative bioavailability of AZD9056 using PK variables Cmax and AUC
Time frame: For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7
2 secondary outcomes
Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F)
Time frame: For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7
Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)
Time frame: Frequent sampling occasions throughout the study 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 23 Jul 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.
Mark Layton study director
AstraZeneca R&D, Alderley Park, UK
Simon Constable principal investigator
ICON Development Solutions, 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 AZD9056 formulation Phase III 50 mg (T), AZD9056 formulation Phase IIb 50 mg (R) and AZD9056 formulation Phase III 200 mg (T) in people with Healthy, 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 23 Jul 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?
Relative bioavailability of AZD9056 using PK variables Cmax and AUC (time frame: For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7). 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 23 Jul 2009.